MONOFOCAL IOLS
This device is manufactured by ABBOTT MEDICAL OPTICS, ABBOTT MEDICAL OPTICS / JOHNSON & JOHNSON SURGICAL VISION, JOHNSON & JOHNSON SURGICAL VISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Visual Disturbances | 1 | Patient |
| 2024 | Eye Injury | 1 | Patient |
| 2024 | Capsular Bag Tear | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 8 | Patient |
| 2024 | Use of Device Problem | 2 | Device |
| 2024 | Scratched Material | 1 | Device |
| 2024 | Mechanical Jam | 1 | Device |
| 2024 | Material Fragmentation | 2 | Device |
| 2024 | Difficult to Insert | 1 | Device |
| 2024 | Difficult to Fold, Unfold or Collapse | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 2 | Device |
| 2024 | Break | 11 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Zonular Dehiscence | 2 | Patient |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Vitreous Loss | 1 | Patient |
| 2023 | Vitreous Detachment | 1 | Patient |
| 2023 | Visual Impairment | 2 | Patient |
| 2023 | Visual Disturbances | 8 | Patient |
| 2023 | Retinal Detachment | 1 | Patient |
| 2023 | Eye Injury | 5 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Capsular Bag Tear | 1 | Patient |
| 2023 | Blurred Vision | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 9 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unstable | 1 | Device |
| 2023 | Scratched Material | 2 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Fragmentation | 3 | Device |
| 2023 | Failure to Fold | 1 | Device |
| 2023 | Ejection Problem | 1 | Device |
| 2023 | Difficult to Insert | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 4 | Device |
| 2023 | Break | 19 | Device |
| 2023 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2022 | Visual Impairment | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unstable | 17 | Device |
| 2022 | Material Split, Cut or Torn | 2 | Device |
| 2022 | Material Fragmentation | 2 | Device |
| 2022 | Inaccurate Delivery | 2 | Device |
| 2022 | Failure to Fold | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 3 | Device |
| 2022 | Delivered as Unsterile Product | 1 | Device |
| 2022 | Break | 16 | Device |
| 2022 | Appropriate Term/Code Not Available | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2021 | Calcified | 2 | Device |
| 2021 | Break | 1 | Device |
| 2020 | Unintended Movement | 43 | Device |
| 2020 | Unexpected Therapeutic Results | 3 | Device |
| 2020 | Separation Problem | 3 | Device |
| 2020 | Scratched Material | 4 | Device |
| 2020 | Product Quality Problem | 2 | Device |
| 2020 | Physical Resistance/Sticking | 1 | Device |
| 2020 | Patient Device Interaction Problem | 1 | Device |
| 2020 | Migration or Expulsion of Device | 2 | Device |
| 2020 | Mechanical Problem | 3 | Device |
| 2020 | Material Twisted/Bent | 2 | Device |
| 2020 | Material Split, Cut or Torn | 6 | Device |
| 2020 | Material Opacification | 2 | Device |
| 2020 | Material Integrity Problem | 1 | Device |
| 2020 | Material Fragmentation | 1 | Device |
| 2020 | Material Discolored | 1 | Device |
| 2020 | Inadequacy of Device Shape and/or Size | 11 | Device |
| 2020 | Failure to Unfold or Unwrap | 2 | Device |
| 2020 | Difficult to Insert | 1 | Device |
| 2020 | Device Handling Problem | 3 | Device |
| 2020 | Device Dislodged or Dislocated | 4 | Device |
| 2020 | Defective Device | 1 | Device |
| 2020 | Crack | 1 | Device |
| 2020 | Contamination /Decontamination Problem | 4 | Device |
| 2020 | Contamination | 3 | Device |
| 2020 | Break | 24 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 92 | Device |