INTRAOCULAR LENS
This device is manufactured by ALCON LABORATORIES, ALCON LABS, ALCON MANUFACTURING / HUNTINGTON, ALCON RESEARCH, ALCON RESEARCH - HUNTINGTON and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Visual Impairment | 1 | Patient |
| 2024 | Visual Disturbances | 2 | Patient |
| 2024 | Prolapse | 2 | Patient |
| 2024 | Pigment Dispersion Syndrome | 1 | Patient |
| 2024 | Intraocular Pressure Increased | 1 | Patient |
| 2024 | Insufficient Information | 13 | Patient |
| 2024 | Dry Eye(s) | 1 | Patient |
| 2024 | Capsular Bag Tear | 1 | Patient |
| 2024 | Blurred Vision | 2 | Patient |
| 2024 | Unintended Ejection | 1 | Device |
| 2024 | Scratched Material | 2 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Opacification | 2 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Failure to Unfold or Unwrap | 1 | Device |
| 2024 | Defective Device | 7 | Device |
| 2024 | Crack | 2 | Device |
| 2024 | Break | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2023 | Visual Impairment | 1 | Patient |
| 2023 | Unspecified Eye / Vision Problem | 1 | Patient |
| 2023 | Insufficient Information | 21 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Eye Pain | 2 | Patient |
| 2023 | Eye Injury | 1 | Patient |
| 2023 | Corneal Edema | 1 | Patient |
| 2023 | Blurred Vision | 1 | Patient |
| 2023 | Unintended Ejection | 2 | Device |
| 2023 | Scratched Material | 2 | Device |
| 2023 | Material Twisted/Bent | 4 | Device |
| 2023 | Failure to Eject | 4 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2023 | Difficult to Fold, Unfold or Collapse | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 2 | Device |
| 2023 | Device Damaged by Another Device | 1 | Device |
| 2023 | Defective Device | 10 | Device |
| 2023 | Defective Component | 1 | Device |
| 2023 | Break | 6 | Device |
| 2023 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Scratched Material | 4 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Failure to Fold | 1 | Device |
| 2022 | Failure to Eject | 1 | Device |
| 2022 | Difficult to Advance | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Appropriate Term/Code Not Available | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Break | 1 | Device |
| 2020 | Patient-Device Incompatibility | 1 | Device |
| 2020 | Break | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Insufficient Information | 1 | Patient |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Unstable | 2 | Device |
| 2019 | Structural Problem | 1 | Device |
| 2019 | Scratched Material | 8 | Device |
| 2019 | Positioning Problem | 2 | Device |
| 2019 | Physical Resistance/Sticking | 1 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | Material Twisted/Bent | 5 | Device |
| 2019 | Material Too Rigid or Stiff | 1 | Device |
| 2019 | Material Split, Cut or Torn | 1 | Device |
| 2019 | Material Rupture | 1 | Device |
| 2019 | Material Opacification | 3 | Device |
| 2019 | Material Integrity Problem | 1 | Device |
| 2019 | Material Deformation | 2 | Device |
| 2019 | Malposition of Device | 2 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Fracture | 2 | Device |
| 2019 | Failure to Unfold or Unwrap | 2 | Device |
| 2019 | Failure to Fold | 1 | Device |
| 2019 | Failure to Align | 1 | Device |
| 2019 | Disconnection | 1 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Difficult to Fold, Unfold or Collapse | 2 | Device |
| 2019 | Device Dislodged or Dislocated | 3 | Device |
| 2019 | Detachment of Device or Device Component | 3 | Device |
| 2019 | Delivered as Unsterile Product | 1 | Device |
| 2019 | Defective Device | 14 | Device |
| 2019 | Defective Component | 7 | Device |
| 2019 | Crack | 2 | Device |
| 2019 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2019 | Contamination /Decontamination Problem | 2 | Device |
| 2019 | Break | 41 | Device |
| 2019 | Appropriate Term/Code Not Available | 6 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2019 | Activation, Positioning or Separation Problem | 1 | Device |
| 2018 | Unexpected Therapeutic Results | 2 | Device |
| 2018 | Sticking | 2 | Device |
| 2018 | Scratched Material | 1 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Positioning Failure | 1 | Device |
| 2018 | Physical Property Issue | 1 | Device |
| 2018 | Patient-Device Incompatibility | 2 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Material Twisted/Bent | 3 | Device |
| 2018 | Material Split, Cut or Torn | 3 | Device |
| 2018 | Material Rupture | 3 | Device |
| 2018 | Material Integrity Problem | 1 | Device |
| 2018 | Malposition of Device | 1 | Device |
| 2018 | Insufficient Information | 4 | Device |
| 2018 | Fracture | 1 | Device |
| 2018 | Failure to Align | 1 | Device |
| 2018 | Entrapment of Device | 1 | Device |
| 2018 | Device Slipped | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 4 | Device |
| 2018 | Device Fell | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 2 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Defective Device | 5 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Crack | 1 | Device |
| 2018 | Calcified | 1 | Device |
| 2018 | Break | 15 | Device |
| 2018 | Appropriate Term/Code Not Available | 7 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Unstable | 1 | Device |
| 2017 | Unexpected Therapeutic Results | 1 | Device |
| 2017 | Torn Material | 1 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2017 | Scratched Material | 2 | Device |
| 2017 | Positioning Problem | 2 | Device |
| 2017 | Physical Property Issue | 1 | Device |
| 2017 | Patient-Device Incompatibility | 8 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Material Separation | 2 | Device |
| 2017 | Material Opacification | 2 | Device |
| 2017 | Material Discolored | 1 | Device |
| 2017 | Material Deformation | 2 | Device |
| 2017 | Malposition of Device | 3 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Insufficient Information | 10 | Device |
| 2017 | Increase in Pressure | 1 | Device |
| 2017 | Human Factors Issue | 1 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Folded | 1 | Device |
| 2017 | Failure to Align | 1 | Device |
| 2017 | Entrapment of Device | 1 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 12 | Device |
| 2017 | Device Displays Incorrect Message | 2 | Device |
| 2017 | Device Dislodged or Dislocated | 4 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Break | 13 | Device |
| 2017 | Bent | 2 | Device |
| 2017 | Appropriate Term/Code Not Available | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2016 | Unstable | 1 | Device |
| 2016 | Unintended Movement | 1 | Device |
| 2016 | Unexpected Therapeutic Results | 1 | Device |
| 2016 | Torn Material | 1 | Device |
| 2016 | Material Twisted/Bent | 1 | Device |
| 2016 | Material Rupture | 1 | Device |
| 2016 | Material Opacification | 1 | Device |
| 2016 | Insufficient Information | 4 | Device |
| 2016 | Improper or Incorrect Procedure or Method | 3 | Device |
| 2016 | Device Operates Differently Than Expected | 4 | Device |
| 2016 | Device Dislodged or Dislocated | 3 | Device |
| 2016 | Component Falling | 1 | Device |
| 2016 | Break | 4 | Device |
| 2016 | Bent | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2015 | Detachment Of Device Component | 1 | Device |
| 2015 | Defective Device | 1 | Device |
| 2014 | Use of Device Problem | 3 | Device |
| 2014 | Torn Material | 1 | Device |
| 2014 | Packaging Problem | 1 | Device |
| 2014 | Malposition of Device | 2 | Device |
| 2014 | Inaccurate Delivery | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 4 | Device |
| 2014 | Delivery System Failure | 1 | Device |
| 2014 | Defective Component | 1 | Device |
| 2014 | Crack | 1 | Device |
| 2014 | Break | 7 | Device |
| 2014 | Appropriate Term/Code Not Available | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2013 | Break | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2007 | Patient-Device Incompatibility | 1 | Device |