LENS, GUIDE, INTRAOCULAR
This device is manufactured by ALCON LABORATORIES, ALCON LABORATORIES IRELAND, ALCON RESEARCH, ALCON RESEARCH - HUNTINGTON.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Visual Disturbances | 1 | Patient |
| 2024 | Prolapse | 1 | Patient |
| 2024 | Insufficient Information | 21 | Patient |
| 2024 | Eye Injury | 1 | Patient |
| 2024 | Corneal Edema | 2 | Patient |
| 2024 | Capsular Bag Tear | 2 | Patient |
| 2024 | Physical Resistance/Sticking | 1 | Device |
| 2024 | Inaccurate Delivery | 1 | Device |
| 2024 | Failure to Fold | 3 | Device |
| 2024 | Failure to Eject | 14 | Device |
| 2024 | Failure to Advance | 4 | Device |
| 2024 | Device Difficult to Setup or Prepare | 1 | Device |
| 2024 | Device Damaged by Another Device | 4 | Device |
| 2024 | Defective Device | 4 | Device |
| 2024 | Defective Component | 3 | Device |
| 2024 | Crack | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Visual Impairment | 1 | Patient |
| 2023 | Insufficient Information | 25 | Patient |
| 2023 | Blurred Vision | 1 | Patient |
| 2023 | Unintended Ejection | 5 | Device |
| 2023 | Scratched Material | 2 | Device |
| 2023 | Material Discolored | 1 | Device |
| 2023 | Failure to Unfold or Unwrap | 1 | Device |
| 2023 | Failure to Eject | 6 | Device |
| 2023 | Failure to Advance | 5 | Device |
| 2023 | Device Markings/Labelling Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 1 | Device |
| 2023 | Device Damaged by Another Device | 6 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2023 | Defective Device | 4 | Device |
| 2023 | Defective Component | 8 | Device |
| 2023 | Crack | 3 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Unintended Ejection | 1 | Device |
| 2022 | Stretched | 1 | Device |
| 2022 | Scratched Material | 3 | Device |
| 2022 | Material Too Rigid or Stiff | 1 | Device |
| 2022 | Material Split, Cut or Torn | 2 | Device |
| 2022 | Failure to Unfold or Unwrap | 2 | Device |
| 2022 | Failure to Eject | 12 | Device |
| 2022 | Failure to Align | 1 | Device |
| 2022 | Failure to Advance | 1 | Device |
| 2022 | Ejection Problem | 1 | Device |
| 2022 | Difficult to Fold, Unfold or Collapse | 2 | Device |
| 2022 | Difficult to Advance | 4 | Device |
| 2022 | Device Damaged by Another Device | 5 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Break | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Output Problem | 1 | Device |
| 2020 | Failure to Deliver | 1 | Device |
| 2019 | Unstable | 1 | Device |
| 2019 | Unsealed Device Packaging | 1 | Device |
| 2019 | Unintended Movement | 1 | Device |
| 2019 | Unintended Ejection | 2 | Device |
| 2019 | Unexpected Therapeutic Results | 2 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2019 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2019 | Self-Activation or Keying | 1 | Device |
| 2019 | Scratched Material | 17 | Device |
| 2019 | Positioning Problem | 7 | Device |
| 2019 | Positioning Failure | 2 | Device |
| 2019 | Physical Resistance/Sticking | 27 | Device |
| 2019 | Output above Specifications | 1 | Device |
| 2019 | Misfire | 3 | Device |
| 2019 | Mechanical Problem | 6 | Device |
| 2019 | Material Twisted/Bent | 1 | Device |
| 2019 | Material Split, Cut or Torn | 17 | Device |
| 2019 | Material Rupture | 1 | Device |
| 2019 | Material Protrusion/Extrusion | 1 | Device |
| 2019 | Material Integrity Problem | 6 | Device |
| 2019 | Material Disintegration | 1 | Device |
| 2019 | Material Discolored | 1 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Malposition of Device | 5 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Image Orientation Incorrect | 1 | Device |
| 2019 | Firing Problem | 2 | Device |
| 2019 | Failure to Unfold or Unwrap | 4 | Device |
| 2019 | Failure to Fold | 3 | Device |
| 2019 | Failure to Deliver | 2 | Device |
| 2019 | Failure to Align | 2 | Device |
| 2019 | Failure to Advance | 16 | Device |
| 2019 | Entrapment of Device | 8 | Device |
| 2019 | Difficult to Open or Close | 1 | Device |
| 2019 | Difficult to Insert | 2 | Device |
| 2019 | Difficult to Fold, Unfold or Collapse | 1 | Device |
| 2019 | Difficult to Advance | 2 | Device |
| 2019 | Difficult or Delayed Positioning | 1 | Device |
| 2019 | Device Slipped | 1 | Device |
| 2019 | Device Fell | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 3 | Device |
| 2019 | Device Damaged by Another Device | 2 | Device |
| 2019 | Device Damaged Prior to Use | 2 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2019 | Detachment of Device or Device Component | 2 | Device |
| 2019 | Defective Device | 25 | Device |
| 2019 | Defective Component | 13 | Device |
| 2019 | Crack | 9 | Device |
| 2019 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2019 | Contamination /Decontamination Problem | 1 | Device |
| 2019 | Contamination | 1 | Device |
| 2019 | Break | 49 | Device |
| 2019 | Appropriate Term/Code Not Available | 4 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2019 | Activation, Positioning or Separation Problem | 21 | Device |
| 2018 | Unstable | 1 | Device |
| 2018 | Unintended Movement | 4 | Device |
| 2018 | Unintended Ejection | 1 | Device |
| 2018 | Torn Material | 9 | Device |
| 2018 | Stretched | 1 | Device |
| 2018 | Sticking | 8 | Device |
| 2018 | Split | 1 | Device |
| 2018 | Separation Failure | 1 | Device |
| 2018 | Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 | Device |
| 2018 | Scratched Material | 28 | Device |
| 2018 | Pressure Problem | 2 | Device |
| 2018 | Premature Activation | 1 | Device |
| 2018 | Positioning Problem | 19 | Device |
| 2018 | Positioning Failure | 2 | Device |
| 2018 | Physical Resistance/Sticking | 13 | Device |
| 2018 | Physical Resistance | 12 | Device |
| 2018 | Patient-Device Incompatibility | 2 | Device |
| 2018 | Partial Blockage | 3 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | Misfire | 2 | Device |
| 2018 | Migration or Expulsion of Device | 2 | Device |
| 2018 | Mechanics Altered | 2 | Device |
| 2018 | Mechanical Problem | 4 | Device |
| 2018 | Mechanical Jam | 6 | Device |
| 2018 | Material Twisted/Bent | 6 | Device |
| 2018 | Material Too Rigid or Stiff | 1 | Device |
| 2018 | Material Split, Cut or Torn | 12 | Device |
| 2018 | Material Rupture | 4 | Device |
| 2018 | Material Perforation | 1 | Device |
| 2018 | Material Opacification | 1 | Device |
| 2018 | Material Integrity Problem | 6 | Device |
| 2018 | Material Fragmentation | 1 | Device |
| 2018 | Material Deformation | 3 | Device |
| 2018 | Malposition of Device | 3 | Device |
| 2018 | Insufficient Information | 5 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 3 | Device |
| 2018 | Firing Problem | 3 | Device |
| 2018 | Failure to Unfold or Unwrap | 1 | Device |
| 2018 | Failure to Infuse | 1 | Device |
| 2018 | Failure to Fold | 1 | Device |
| 2018 | Failure to Eject | 1 | Device |
| 2018 | Failure to Deliver | 1 | Device |
| 2018 | Failure to Advance | 6 | Device |
| 2018 | Expulsion | 1 | Device |
| 2018 | Explosion | 1 | Device |
| 2018 | Entrapment of Device | 3 | Device |
| 2018 | Ejection Problem | 1 | Device |
| 2018 | Difficult to Remove | 5 | Device |
| 2018 | Difficult to Insert | 7 | Device |
| 2018 | Difficult to Fold, Unfold or Collapse | 5 | Device |
| 2018 | Difficult to Advance | 3 | Device |
| 2018 | Difficult or Delayed Positioning | 1 | Device |
| 2018 | Device Slipped | 2 | Device |
| 2018 | Device Operates Differently Than Expected | 23 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 3 | Device |
| 2018 | Device Damaged by Another Device | 1 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2018 | Detachment of Device or Device Component | 4 | Device |
| 2018 | Detachment Of Device Component | 3 | Device |
| 2018 | Delivery System Failure | 1 | Device |
| 2018 | Defective Device | 30 | Device |
| 2018 | Defective Component | 11 | Device |
| 2018 | Decrease in Pressure | 1 | Device |
| 2018 | Crack | 6 | Device |
| 2018 | Contamination /Decontamination Problem | 1 | Device |
| 2018 | Contamination | 3 | Device |
| 2018 | Computer Software Problem | 1 | Device |
| 2018 | Component Missing | 2 | Device |
| 2018 | Component Falling | 1 | Device |
| 2018 | Break | 52 | Device |
| 2018 | Bent | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 9 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2018 | Activation, Positioning or Separation Problem | 7 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Unintended System Motion | 1 | Device |
| 2017 | Unintended Movement | 2 | Device |
| 2017 | Torn Material | 6 | Device |
| 2017 | Sticking | 7 | Device |
| 2017 | Scratched Material | 2 | Device |
| 2017 | Pressure Problem | 2 | Device |
| 2017 | Premature Activation | 2 | Device |
| 2017 | Power Conditioning Problem | 1 | Device |
| 2017 | Positioning Problem | 3 | Device |
| 2017 | Positioning Failure | 2 | Device |
| 2017 | Physical Resistance/Sticking | 1 | Device |
| 2017 | Physical Resistance | 3 | Device |
| 2017 | Partial Blockage | 5 | Device |
| 2017 | Optical Distortion | 1 | Device |
| 2017 | Mechanical Problem | 2 | Device |
| 2017 | Mechanical Jam | 2 | Device |
| 2017 | Material Rupture | 3 | Device |
| 2017 | Material Integrity Problem | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Malposition of Device | 2 | Device |
| 2017 | Insufficient Information | 7 | Device |
| 2017 | Increase in Pressure | 1 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2017 | Inaccurate Delivery | 3 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2017 | Folded | 4 | Device |
| 2017 | Failure to Unfold or Unwrap | 1 | Device |
| 2017 | Failure to Eject | 1 | Device |
| 2017 | Extrusion | 1 | Device |
| 2017 | Entrapment of Device | 3 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Difficult to Advance | 1 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 19 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Detachment Of Device Component | 5 | Device |
| 2017 | Defective Device | 1 | Device |
| 2017 | Defective Component | 1 | Device |
| 2017 | Cut In Material | 1 | Device |
| 2017 | Crack | 2 | Device |
| 2017 | Break | 13 | Device |
| 2017 | Bent | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2017 | Activation, Positioning or Separation Problem | 2 | Device |
| 2016 | Unintended Movement | 1 | Device |
| 2016 | Unintended Ejection | 2 | Device |
| 2016 | Torn Material | 2 | Device |
| 2016 | Scratched Material | 1 | Device |
| 2016 | Positioning Problem | 2 | Device |
| 2016 | Migration or Expulsion of Device | 2 | Device |
| 2016 | Mechanical Jam | 1 | Device |
| 2016 | Material Twisted/Bent | 1 | Device |
| 2016 | Material Rupture | 1 | Device |
| 2016 | Malposition of Device | 1 | Device |
| 2016 | Insufficient Information | 10 | Device |
| 2016 | Folded | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 4 | Device |
| 2016 | Detachment of Device or Device Component | 1 | Device |
| 2016 | Detachment Of Device Component | 1 | Device |
| 2016 | Component Missing | 1 | Device |
| 2016 | Burst Container or Vessel | 1 | Device |
| 2016 | Break | 6 | Device |
| 2016 | Bent | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2016 | Activation, Positioning or Separation Problem | 1 | Device |