IMPLANT, EYE VALVE
This device is manufactured by ALCON PRECISION DEVICE - SINKING SPRING, ALCON RESEARCH - HUNTINGTON, OPTONOL, OPTONOL - COMMUNICATION CENTER.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 1 | Patient |
| 2023 | Insufficient Information | 6 | Patient |
| 2023 | Fibrosis | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | Failure to Eject | 3 | Device |
| 2023 | Failure to Discharge | 1 | Device |
| 2023 | Ejection Problem | 1 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | Failure to Deliver | 2 | Device |
| 2022 | Complete Blockage | 1 | Device |
| 2021 | Device Operates Differently Than Expected | 1 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2019 | Positioning Problem | 1 | Device |
| 2019 | Output Problem | 1 | Device |
| 2019 | Obstruction of Flow | 1 | Device |
| 2019 | No Flow | 2 | Device |
| 2019 | Migration or Expulsion of Device | 2 | Device |
| 2019 | Mechanical Problem | 2 | Device |
| 2019 | Material Twisted/Bent | 1 | Device |
| 2019 | Material Too Rigid or Stiff | 1 | Device |
| 2019 | Material Protrusion/Extrusion | 1 | Device |
| 2019 | Material Erosion | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Inadequate Filtration Process | 1 | Device |
| 2019 | Filtration Problem | 1 | Device |
| 2019 | Failure to Eject | 1 | Device |
| 2019 | Failure to Deliver | 2 | Device |
| 2019 | Defective Device | 2 | Device |
| 2019 | Defective Component | 1 | Device |
| 2019 | Complete Blockage | 3 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2019 | Activation, Positioning or Separation Problem | 1 | Device |
| 2019 | Activation Problem | 1 | Device |
| 2018 | Intraocular Pressure Increased | 2 | Patient |
| 2018 | Separation Failure | 2 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Patient-Device Incompatibility | 2 | Device |
| 2018 | Partial Blockage | 1 | Device |
| 2018 | Optical Obstruction | 3 | Device |
| 2018 | Occlusion Within Device | 3 | Device |
| 2018 | Obstruction of Flow | 1 | Device |
| 2018 | No Flow | 5 | Device |
| 2018 | Migration | 1 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Material Protrusion/Extrusion | 2 | Device |
| 2018 | Malposition of Device | 1 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Infusion or Flow Problem | 1 | Device |
| 2018 | Inadequate Filtration Process | 1 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2018 | Firing Problem | 1 | Device |
| 2018 | Filtration Problem | 1 | Device |
| 2018 | Extrusion | 1 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 5 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Defective Component | 2 | Device |
| 2018 | Complete Blockage | 7 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2017 | Intraocular Pressure Decreased | 1 | Patient |
| 2017 | Blurred Vision | 1 | Patient |
| 2017 | Appropriate Term / Code Not Available | 1 | Patient |
| 2017 | Retraction Problem | 1 | Device |
| 2017 | Pressure Problem | 1 | Device |
| 2017 | Positioning Failure | 2 | Device |
| 2017 | Patient-Device Incompatibility | 1 | Device |
| 2017 | Occlusion Within Device | 5 | Device |
| 2017 | Obstruction of Flow | 1 | Device |
| 2017 | No Flow | 3 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Material Protrusion/Extrusion | 1 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Insufficient Information | 2 | Device |
| 2017 | Filtration Problem | 3 | Device |
| 2017 | Failure to Advance | 1 | Device |
| 2017 | Failure of Device to Self-Test | 1 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 15 | Device |
| 2017 | Device Inoperable | 1 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Complete Blockage | 5 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2016 | Unintended Movement | 1 | Device |
| 2016 | Positioning Problem | 1 | Device |
| 2016 | Occlusion Within Device | 2 | Device |
| 2016 | Obstruction of Flow | 1 | Device |
| 2016 | No Flow | 5 | Device |
| 2016 | Material Protrusion/Extrusion | 1 | Device |
| 2016 | Insufficient Information | 4 | Device |
| 2016 | Insufficient Flow or Under Infusion | 1 | Device |
| 2016 | Inadequate Filtration Process | 1 | Device |
| 2016 | Filtration Problem | 1 | Device |
| 2016 | Excess Flow or Over-Infusion | 1 | Device |
| 2016 | Entrapment of Device | 1 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 6 | Device |
| 2016 | Device Dislodged or Dislocated | 1 | Device |
| 2016 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2016 | Complete Blockage | 3 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2015 | Red Eye(s) | 1 | Patient |
| 2015 | Intraocular Pressure Increased | 1 | Patient |
| 2015 | Hyphema | 1 | Patient |
| 2015 | Blurred Vision | 1 | Patient |
| 2015 | Appropriate Term / Code Not Available | 1 | Patient |
| 2015 | Positioning Problem | 1 | Device |
| 2015 | Positioning Failure | 1 | Device |
| 2015 | Occlusion Within Device | 1 | Device |
| 2015 | No Flow | 2 | Device |
| 2015 | Malposition of Device | 2 | Device |
| 2015 | Leak/Splash | 1 | Device |
| 2015 | Insufficient Information | 5 | Device |
| 2015 | Device Operates Differently Than Expected | 7 | Device |
| 2015 | Complete Blockage | 3 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Unstable | 1 | Device |
| 2014 | Unintended Collision | 1 | Device |
| 2014 | Patient-Device Incompatibility | 1 | Device |
| 2014 | Partial Blockage | 1 | Device |
| 2014 | Obstruction of Flow | 2 | Device |
| 2014 | No Flow | 7 | Device |
| 2014 | Mechanical Jam | 1 | Device |
| 2014 | Malposition of Device | 5 | Device |
| 2014 | Insufficient Information | 2 | Device |
| 2014 | Inaccurate Delivery | 3 | Device |
| 2014 | Improper Device Output | 1 | Device |
| 2014 | Failure to Deliver | 11 | Device |
| 2014 | Excess Flow or Over-Infusion | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 2 | Device |
| 2014 | Defective Device | 1 | Device |
| 2014 | Complete Blockage | 25 | Device |
| 2014 | Appropriate Term/Code Not Available | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2013 | Unintended Movement | 1 | Device |
| 2013 | Sticking | 1 | Device |
| 2013 | Positioning Problem | 2 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Malposition of Device | 31 | Device |
| 2013 | Low Readings | 1 | Device |
| 2013 | Leak/Splash | 4 | Device |
| 2013 | Insufficient Information | 4 | Device |
| 2013 | Inadequate Filtration Process | 1 | Device |
| 2013 | Fluid/Blood Leak | 1 | Device |
| 2013 | Failure to Deliver | 2 | Device |
| 2013 | Fail-Safe Design Failure | 1 | Device |
| 2013 | Extrusion | 1 | Device |
| 2013 | Excess Flow or Over-Infusion | 1 | Device |
| 2013 | Difficult to Remove | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 6 | Device |
| 2013 | Device Dislodged or Dislocated | 3 | Device |
| 2013 | Detachment of Device or Device Component | 1 | Device |
| 2013 | Complete Blockage | 3 | Device |
| 2013 | Appropriate Term/Code Not Available | 3 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2012 | Use of Device Problem | 1 | Device |
| 2012 | No Pressure | 1 | Device |
| 2012 | Malposition of Device | 9 | Device |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Inadequate Filtration Process | 2 | Device |
| 2012 | Filtration Problem | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 5 | Device |
| 2012 | Device Dislodged or Dislocated | 2 | Device |
| 2012 | Complete Blockage | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 9 | Device |