XEN 45 GTS

IMPLANT, EYE VALVE

This device is manufactured by ALLERGAN, ALLERGAN (IRVINE).

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-07-15 Injury Failure of Implant None
2024-07-11 Malfunction No Clinical Signs, Symptoms or Conditions None
2024-07-11 Injury Erosion None
2024-07-09 Injury Failure of Implant None
2024-07-04 Injury Erosion, Endophthalmitis, Eye Injury, Intraocular Pressure Increased, Appropriate Term / Code Not Available None
2024-06-24 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-06-11 Injury Eye Injury, Intraocular Pressure Increased None
2024-06-07 Injury Erosion, Intraocular Pressure Increased Device Appears to Trigger Rejection
2024-06-06 Injury Intraocular Pressure Increased Adverse Event Without Identified Device or Use Problem
2024-05-22 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-05-17 Injury Eye Injury, Intraocular Pressure Increased, Perforation Adverse Event Without Identified Device or Use Problem
2024-04-15 Malfunction No Clinical Signs, Symptoms or Conditions Complete Blockage
2024-04-08 Malfunction No Clinical Signs, Symptoms or Conditions Device Contamination with Chemical or Other Material
2024-04-04 Injury Choroidal Hemorrhage Adverse Event Without Identified Device or Use Problem
2024-04-03 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-03-28 Malfunction No Clinical Signs, Symptoms or Conditions None
2024-03-20 Malfunction No Clinical Signs, Symptoms or Conditions None
2024-03-06 Injury Erosion Device Appears to Trigger Rejection
2024-02-28 Malfunction No Clinical Signs, Symptoms or Conditions None
2024-02-22 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-02-21 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-02-19 Injury Visual Impairment, Choroidal Hemorrhage Adverse Event Without Identified Device or Use Problem
2024-02-07 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-01-31 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-01-22 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-01-19 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-01-17 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2024-01-09 Malfunction No Clinical Signs, Symptoms or Conditions None
2024-01-04 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-12-27 Injury Erosion, Endophthalmitis, Eye Injury, Glaucoma, Intraocular Pressure Increased, Appropriate Term / Code Not Available Device Appears to Trigger Rejection, Migration
2023-12-27 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-12-21 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-12-18 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-10-26 Injury Glaucoma, Intraocular Infection, Intraocular Pressure Increased Adverse Event Without Identified Device or Use Problem
2023-10-26 Injury Endophthalmitis Adverse Event Without Identified Device or Use Problem
2023-10-26 Injury Fluid Discharge Adverse Event Without Identified Device or Use Problem
2023-10-17 Injury Erosion, Cataract, Fluid Discharge Device Appears to Trigger Rejection
2023-10-15 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-10-05 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-10-03 Injury Intraocular Pressure Increased, Visual Impairment Adverse Event Without Identified Device or Use Problem
2023-09-12 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-09-05 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-08-28 Injury Erosion Device Appears to Trigger Rejection
2023-08-26 Injury Corneal Decompensation, Intraocular Pressure Increased, Loss of Vision Adverse Event Without Identified Device or Use Problem
2023-08-04 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-07-26 Injury Failure of Implant, No Clinical Signs, Symptoms or Conditions Complete Blockage, No Apparent Adverse Event
2023-07-06 Injury Eye Injury, Intraocular Pressure Increased, Fluid Discharge Adverse Event Without Identified Device or Use Problem
2023-07-03 Injury Eye Injury, Loss of Vision, Fibrosis Malposition of Device
2023-07-03 Injury Cataract Complete Blockage, Migration
2023-04-24 Injury Erosion Device Appears to Trigger Rejection
2023-03-29 Malfunction No Clinical Signs, Symptoms or Conditions None
2023-03-14 Injury Erosion, Endophthalmitis Device Appears to Trigger Rejection
2023-02-14 Malfunction No Clinical Signs, Symptoms or Conditions Physical Resistance/Sticking
2023-02-10 Injury Eye Injury Migration
2023-02-03 Injury Endophthalmitis Adverse Event Without Identified Device or Use Problem
2022-11-22 Malfunction None Dull, Blunt
2022-11-10 Injury Intraocular Pressure Increased Adverse Event Without Identified Device or Use Problem
2022-11-10 Injury Intraocular Pressure Increased Adverse Event Without Identified Device or Use Problem
2022-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2022-11-02 Injury None Device Appears to Trigger Rejection
2022-09-07 Injury None Adverse Event Without Identified Device or Use Problem
2022-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2022-08-20 Malfunction None Material Twisted/Bent
2022-08-20 Injury None Complete Blockage, Migration
2022-07-19 Malfunction None Physical Resistance/Sticking
2022-07-19 Injury None Physical Resistance/Sticking
2022-07-06 Malfunction None Fracture, Material Twisted/Bent
2022-07-06 Injury None Device Appears to Trigger Rejection, Migration
2022-04-13 Malfunction None Physical Resistance/Sticking
2022-04-12 Malfunction None Mechanical Jam
2022-03-31 Injury None Device Appears to Trigger Rejection
2022-03-24 Malfunction None Dull, Blunt
2022-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2020-01-16 Injury None Insufficient Information
2020-01-16 Injury None Insufficient Information
2020-01-08 Malfunction None Fracture, Malposition of Device, Physical Resistance/Sticking
2020-01-07 Injury None Malposition of Device, Migration
2019-12-03 Malfunction None Device Alarm System, Malposition of Device
2019-10-18 Malfunction None Retraction Problem
2019-09-26 Injury None Adverse Event Without Identified Device or Use Problem
2019-09-24 Injury None Improper or Incorrect Procedure or Method, Insufficient Information, Migration
2019-09-16 Injury None Adverse Event Without Identified Device or Use Problem
2019-09-05 Injury None Adverse Event Without Identified Device or Use Problem
2019-09-05 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-27 Injury None Fracture, Migration
2019-08-22 Malfunction None Mechanical Jam
2019-08-21 Malfunction None Fracture
2019-08-21 Injury None Positioning Failure
2019-08-21 Malfunction None Physical Resistance/Sticking
2019-08-19 Injury None Migration
2019-08-13 Injury None Malposition of Device
2019-08-12 Malfunction None Physical Resistance/Sticking
2019-08-12 Malfunction None Break, Mechanical Jam
2019-08-08 Injury None Migration
2019-08-06 Malfunction None Mechanical Jam
2019-08-05 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-30 Malfunction None Retraction Problem
2019-07-26 Injury None Malposition of Device
2019-07-25 Injury None Migration
2019-07-22 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-22 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-19 Malfunction None Physical Resistance/Sticking
2019-07-18 Malfunction None Mechanical Jam
2019-07-17 Injury None Fracture
2019-07-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-16 Malfunction None Positioning Failure, Retraction Problem
2019-07-15 Injury None Patient-Device Incompatibility
2019-07-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-10 Malfunction None Mechanical Jam
2019-07-09 Injury None Fracture, Material Twisted/Bent
2019-07-09 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-05 Malfunction None Retraction Problem
2019-07-05 Malfunction None Retraction Problem
2019-06-28 Malfunction None Improper or Incorrect Procedure or Method
2019-06-24 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-20 Malfunction None Mechanical Jam
2019-06-19 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-19 Injury None Migration
2019-06-19 Malfunction None Fracture
2019-06-18 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-17 Malfunction None Physical Resistance/Sticking
2019-06-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-14 Injury None Migration
2019-06-13 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-13 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-12 Malfunction None Improper or Incorrect Procedure or Method, Physical Resistance/Sticking
2019-06-12 Malfunction None Break
2019-06-11 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-11 Malfunction None Defective Component
2019-06-04 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-04 Malfunction None Defective Component
2019-06-04 Malfunction None Physical Resistance/Sticking
2019-06-04 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-04 Malfunction None Defective Component
2019-05-31 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-31 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-28 Malfunction None Defective Component
2019-05-28 Malfunction None Defective Component
2019-05-22 Injury None Off-Label Use
2019-05-22 Malfunction None Retraction Problem, Physical Resistance/Sticking
2019-05-16 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-15 Injury None Partial Blockage, Migration
2019-05-14 Malfunction None Defective Component
2019-05-14 Malfunction None Defective Component
2019-05-10 Injury None Complete Blockage
2019-05-02 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-30 Malfunction None Malposition of Device, Physical Resistance/Sticking
2019-04-30 Malfunction None Malposition of Device, Physical Resistance/Sticking
2019-04-30 Malfunction None Malposition of Device, Physical Resistance/Sticking
2019-04-29 Malfunction None Retraction Problem, Mechanical Jam
2019-04-28 Malfunction None Fracture
2019-04-26 Injury None Malposition of Device
2019-04-26 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-25 Injury None Complete Blockage
2019-04-25 Injury None Off-Label Use
2019-04-22 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-19 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-19 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-18 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-17 Injury None Malposition of Device
2019-04-16 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-16 Malfunction None Physical Resistance/Sticking
2019-04-15 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-11 Injury None Off-Label Use
2019-04-10 Injury None Fracture, Improper or Incorrect Procedure or Method, Migration
2019-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-09 Injury None Migration
2019-04-08 Injury None Fracture, Material Too Rigid or Stiff, Migration
2019-04-05 Injury None Complete Blockage
2019-04-03 Injury None Migration
2019-04-02 Malfunction None Retraction Problem
2019-04-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-28 Malfunction None Mechanical Jam
2019-03-28 Injury None Break, Migration
2019-03-26 Malfunction None Retraction Problem
2019-03-25 Injury None Break
2019-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-15 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-12 Malfunction None Mechanical Jam
2019-03-12 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-11 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-11 Malfunction None Fracture
2019-03-08 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-07 Malfunction None Retraction Problem
2019-03-06 Injury None Malposition of Device
2019-03-06 Malfunction None Retraction Problem, Malposition of Device, Physical Resistance/Sticking
2019-03-05 Malfunction None Retraction Problem, Mechanical Jam
2019-03-05 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-04 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-04 Malfunction None Defective Component
2019-03-01 Injury None Migration
2019-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-28 Malfunction None Physical Resistance/Sticking
2019-02-27 Malfunction None Physical Resistance/Sticking
2019-02-25 Malfunction None Mechanical Jam
2019-02-21 Injury None Malposition of Device, Activation, Positioning or Separation Problem
2019-02-19 Malfunction None Mechanical Jam
2019-02-19 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-14 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-14 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-14 Malfunction None Physical Resistance/Sticking
2019-02-07 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-05 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-04 Injury None Migration
2019-01-31 Malfunction None Malposition of Device, Physical Resistance/Sticking
2019-01-30 Malfunction None Mechanical Jam
2019-01-30 Malfunction None Material Twisted/Bent
2019-01-29 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-29 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-24 Malfunction None Retraction Problem
2019-01-23 Malfunction None Mechanical Jam
2019-01-22 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-22 Injury None Material Twisted/Bent, Migration
2019-01-22 Injury None Migration
2019-01-22 Injury None Complete Blockage
2019-01-22 Injury None Improper or Incorrect Procedure or Method
2019-01-22 Injury None Migration
2019-01-22 Malfunction None Malposition of Device, Mechanical Jam
2019-01-15 Injury None Insufficient Information
2019-01-15 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-15 Injury None Insufficient Information
2019-01-14 Injury None Insufficient Information
2019-01-14 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-10 Injury None Migration
2019-01-10 Injury None Malposition of Device
2019-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-09 Injury None Malposition of Device
2019-01-09 Injury None Malposition of Device
2019-01-01 Injury None Insufficient Information
2018-12-24 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-15 Injury None Off-Label Use
2018-12-15 Injury None Material Twisted/Bent
2018-12-13 Injury None Fracture, Adverse Event Without Identified Device or Use Problem
2018-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-10 Malfunction None Break, Malposition of Device
2018-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-04 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-03 Malfunction None Mechanical Jam
2018-12-03 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-29 Injury None Fracture
2018-11-28 Injury None Migration
2018-11-28 Malfunction None Material Deformation
2018-11-21 Malfunction None Retraction Problem, Mechanical Jam
2018-11-20 Malfunction None Break
2018-11-20 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-15 Malfunction None Mechanical Jam
2018-11-15 Malfunction None Device Contamination with Chemical or Other Material
2018-11-14 Injury None Insufficient Information
2018-11-12 Malfunction None Mechanical Jam
2018-11-12 Malfunction None Mechanical Jam
2018-11-09 Malfunction None Mechanical Jam
2018-11-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-06 Injury None Positioning Failure
2018-11-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-28 Malfunction None Mechanical Jam
2018-10-24 Injury None Complete Blockage
2018-10-18 Malfunction None Mechanical Jam
2018-10-17 Injury None Break
2018-10-16 Injury None Migration
2018-10-15 Injury None Off-Label Use
2018-10-15 Injury None Improper or Incorrect Procedure or Method, Adverse Event Without Identified Device or Use Problem
2018-10-15 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-12 Malfunction None Mechanical Jam
2018-10-10 Malfunction None Difficult or Delayed Positioning, Fracture
2018-10-09 Malfunction None Material Too Rigid or Stiff
2018-10-09 Malfunction None Retraction Problem
2018-10-08 Injury None Material Deformation
2018-10-05 Malfunction None Physical Resistance/Sticking
2018-10-03 Malfunction None Mechanical Jam
2018-10-03 Malfunction None Positioning Failure
2018-10-02 Malfunction None Mechanical Jam
2018-10-01 Injury None Fracture, Off-Label Use
2018-10-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-26 Malfunction None Break, Mechanical Jam
2018-09-25 Injury None Migration
2018-09-24 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-21 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-15 Injury None Migration
2018-09-12 Malfunction None Break, Activation, Positioning or Separation Problem
2018-09-07 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-31 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-30 Malfunction None Material Twisted/Bent, Mechanical Jam
2018-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-22 Malfunction None Mechanical Jam
2018-08-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-16 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-15 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-10 Malfunction None Defective Component
2018-08-07 Malfunction None Positioning Failure
2018-07-31 Malfunction None Mechanical Jam
2018-07-31 Malfunction None Mechanical Jam
2018-07-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-25 Injury None Positioning Failure
2018-07-24 Malfunction None Material Too Rigid or Stiff
2018-07-24 Malfunction None Break, Activation, Positioning or Separation Problem
2018-07-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-15 Injury None Complete Blockage
2018-07-12 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-12 Injury None Migration
2018-07-12 Injury None Fracture, Migration
2018-07-11 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-10 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-10 Malfunction None Retraction Problem
2018-07-10 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-27 Malfunction None Retraction Problem, Malposition of Device
2018-06-26 Malfunction None Material Too Rigid or Stiff
2018-06-22 Malfunction None Break, Incomplete or Missing Packaging
2018-06-20 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-20 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-19 Malfunction None Activation, Positioning or Separation Problem
2018-06-18 Malfunction None Mechanical Jam
2018-06-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-13 Malfunction None Break
2018-06-01 Injury None Migration or Expulsion of Device
2018-05-31 Injury None Activation, Positioning or Separation Problem
2018-05-31 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-22 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-21 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-21 Injury None Use of Device Problem
2018-05-16 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-15 Malfunction None Activation, Positioning or Separation Problem
2018-05-15 Injury None Fracture
2018-05-15 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-15 Malfunction None Activation, Positioning or Separation Problem
2018-05-14 Injury Eye Injury, Intraocular Pressure Increased Adverse Event Without Identified Device or Use Problem
2018-05-09 Injury None Activation, Positioning or Separation Problem
2018-05-08 Malfunction None Retraction Problem
2018-05-08 Malfunction None Mechanical Jam
2018-05-03 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-30 Injury None Insufficient Information
2018-04-26 Injury None Migration or Expulsion of Device
2018-04-25 Injury Intraocular Pressure Increased Complete Blockage
2018-04-23 Injury None Complete Blockage, Improper or Incorrect Procedure or Method, Adverse Event Without Identified Device or Use Problem
2018-04-23 Injury None Complete Blockage, Improper or Incorrect Procedure or Method, Adverse Event Without Identified Device or Use Problem
2018-04-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-18 Malfunction None Activation, Positioning or Separation Problem
2018-04-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-18 Malfunction None Partial Blockage
2018-04-09 Injury None Fracture
2018-04-05 Injury None Partial Blockage
2018-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-03 Injury None Fracture, Use of Device Problem
2018-03-29 Injury None Difficult To Position
2018-03-28 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-25 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-16 Injury None Partial Blockage
2018-03-15 Injury None Migration or Expulsion of Device
2018-03-15 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-15 Injury None Deformation Due to Compressive Stress
2018-03-12 Malfunction None Break, Difficult or Delayed Positioning
2018-03-09 Injury None Migration or Expulsion of Device
2018-03-09 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-27 Injury None Off-Label Use
2018-02-27 Injury None Complete Blockage, Off-Label Use
2018-02-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-21 Malfunction None Activation, Positioning or Separation Problem
2018-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-20 Malfunction None Break
2018-02-15 Injury None Break
2018-02-12 Injury None Partial Blockage
2018-02-12 Injury Intraocular Pressure Increased Adverse Event Without Identified Device or Use Problem
2018-02-06 Injury None Malposition of Device
2018-02-02 Injury None Migration or Expulsion of Device
2018-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-31 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-31 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-31 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-30 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-29 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-25 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-25 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-25 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-25 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-25 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2018-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-23 Malfunction None Partial Blockage, Difficult To Position
2018-01-15 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-15 Injury None Fracture
2018-01-14 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-12 Injury None Migration or Expulsion of Device
2018-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-08 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-05 Injury None Migration or Expulsion of Device
2018-01-02 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-01 Injury None Complete Blockage, Off-Label Use, Material Deformation
2018-01-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-22 Injury None Migration or Expulsion of Device
2017-12-21 Malfunction None Expiration Date Error
2017-12-21 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2017-12-21 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2017-12-21 Injury None Fracture, Migration or Expulsion of Device
2017-12-21 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2017-12-21 Malfunction None Expiration Date Error, Device Markings/Labelling Problem
2017-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-06 Injury None Device Inoperable
2017-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-05 Malfunction None Migration or Expulsion of Device, Activation Failure
2017-12-04 Malfunction None Difficult or Delayed Positioning
2017-12-04 Malfunction None Fracture, Activation, Positioning or Separation Problem
2017-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-28 Injury None Fracture
2017-11-22 Malfunction None Activation, Positioning or Separation Problem
2017-11-15 Malfunction None Activation, Positioning or Separation Problem
2017-11-14 Malfunction None Activation, Positioning or Separation Problem
2017-11-14 Malfunction None Activation, Positioning or Separation Problem
2017-11-14 Malfunction None Fracture, Activation, Positioning or Separation Problem
2017-11-14 Malfunction None Difficult or Delayed Positioning
2017-11-14 Injury None Partial Blockage
2017-11-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-13 Injury None Partial Blockage, Difficult To Position, Deformation Due to Compressive Stress
2017-11-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-31 Injury None Partial Blockage
2017-10-31 Injury None Partial Blockage
2017-10-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-24 Malfunction None Activation, Positioning or Separation Problem
2017-10-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-19 Injury None Break
2017-10-19 Injury None Coiled, Migration or Expulsion of Device
2017-10-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-15 Injury None Fracture
2017-09-07 Injury None Use of Device Problem, Activation, Positioning or Separation Problem
2017-09-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-28 Injury None Use of Device Problem
2017-08-23 Injury None Partial Blockage
2017-08-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-21 Injury None Patient-Device Incompatibility
2017-08-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-07 Injury None Fracture
2017-08-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-20 Injury None Fracture
2017-07-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-29 Injury None Migration or Expulsion of Device
2017-06-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-14 Injury None Patient-Device Incompatibility
2017-06-14 Injury None Patient-Device Incompatibility
2017-06-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-08 Injury None Fracture
2017-06-06 Injury None Fracture
2017-06-01 Injury None Patient-Device Incompatibility
2017-05-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-29 Injury None Partial Blockage
2017-05-29 Injury None Partial Blockage
2017-05-29 Injury None Migration or Expulsion of Device
2017-05-19 Injury None Difficult To Position
2017-05-08 Malfunction None Activation, Positioning or Separation Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Malfunction None Material Deformation
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Patient-Device Incompatibility
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Partial Blockage
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-15 Injury None Partial Blockage
2017-04-05 Injury None No Apparent Adverse Event
2017-04-04 Injury None No Apparent Adverse Event
2017-03-30 Injury None No Apparent Adverse Event
2017-03-22 Injury None Migration or Expulsion of Device, Deformation Due to Compressive Stress
2017-03-22 Injury None Deformation Due to Compressive Stress
2017-03-21 Malfunction None Break
2017-03-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-10 Injury None Fracture, Extrusion
2017-03-01 Injury None Extrusion
2017-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-28 Injury None No Apparent Adverse Event
2017-02-24 Malfunction None Fracture
2017-02-24 Injury None Fracture
2017-02-09 Malfunction None Break
2017-01-12 Malfunction None Activation, Positioning or Separation Problem
2017-01-10 Malfunction None Break
2016-12-06 Injury None No Apparent Adverse Event
2016-11-24 Injury None Device Contamination with Chemical or Other Material
2016-11-22 Malfunction None Component Missing
2016-11-21 Malfunction None Break, Fracture
2016-11-08 Malfunction None Component Missing
2016-09-01 Malfunction None Component Missing
2016-06-17 Injury None Activation, Positioning or Separation Problem
2016-05-25 Injury None Migration or Expulsion of Device
2015-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2015-09-17 Injury None Adverse Event Without Identified Device or Use Problem
2015-08-25 Injury None Fracture, Use of Device Problem
2015-07-23 Injury None Adverse Event Without Identified Device or Use Problem
2015-06-15 Injury None Adverse Event Without Identified Device or Use Problem
2015-06-15 Injury None Adverse Event Without Identified Device or Use Problem
2015-06-15 Injury None Adverse Event Without Identified Device or Use Problem
2015-06-15 Injury None Adverse Event Without Identified Device or Use Problem
2015-06-15 Injury None Adverse Event Without Identified Device or Use Problem
2015-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2014-06-24 Injury None No Apparent Adverse Event
2014-03-31 Injury None Patient-Device Incompatibility