INTRAOCULAR LENS
This device is manufactured by STAAR SURGICAL COMPANY.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Visual Disturbances | 24 | Patient |
| 2024 | Toxic Anterior Segment Syndrome (TASS) | 33 | Patient |
| 2024 | Retinal Detachment | 2 | Patient |
| 2024 | Red Eye(s) | 2 | Patient |
| 2024 | Pupillary Block | 1 | Patient |
| 2024 | Macular Edema | 1 | Patient |
| 2024 | Iritis | 3 | Patient |
| 2024 | Intraocular Pressure Increased | 24 | Patient |
| 2024 | Inflammation | 6 | Patient |
| 2024 | Hyphema | 2 | Patient |
| 2024 | Headache | 5 | Patient |
| 2024 | Halo | 8 | Patient |
| 2024 | Eye Pain | 4 | Patient |
| 2024 | Endophthalmitis | 1 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Corneal Edema | 3 | Patient |
| 2024 | Cataract | 10 | Patient |
| 2024 | Blurred Vision | 64 | Patient |
| 2024 | Appropriate Term / Code Not Available | 53 | Patient |
| 2024 | Unintended Movement | 7 | Device |
| 2024 | Patient-Device Incompatibility | 3 | Device |
| 2024 | Packaging Problem | 1 | Device |
| 2024 | Optical Problem | 12 | Device |
| 2024 | Off-Label Use | 46 | Device |
| 2024 | No Apparent Adverse Event | 132 | Device |
| 2024 | Misfocusing | 8 | Device |
| 2024 | Inadequacy of Device Shape and/or Size | 61 | Device |
| 2024 | Device Dislodged or Dislocated | 9 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 396 | Device |
| 2023 | Vitreous Floaters | 2 | Patient |
| 2023 | Visual Disturbances | 29 | Patient |
| 2023 | Uveitis | 3 | Patient |
| 2023 | Toxic Anterior Segment Syndrome (TASS) | 4 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Retinal Detachment | 1 | Patient |
| 2023 | Red Eye(s) | 3 | Patient |
| 2023 | Pupillary Block | 7 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Intraocular Pressure Increased | 45 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Inflammation | 6 | Patient |
| 2023 | Hyphema | 1 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Halo | 27 | Patient |
| 2023 | Glaucoma | 4 | Patient |
| 2023 | Eye Pain | 3 | Patient |
| 2023 | Endophthalmitis | 1 | Patient |
| 2023 | Dry Eye(s) | 2 | Patient |
| 2023 | Discomfort | 5 | Patient |
| 2023 | Corneal Edema | 3 | Patient |
| 2023 | Cataract | 12 | Patient |
| 2023 | Capsular Bag Tear | 2 | Patient |
| 2023 | Blurred Vision | 177 | Patient |
| 2023 | Appropriate Term / Code Not Available | 116 | Patient |
| 2023 | Unintended Movement | 24 | Device |
| 2023 | Unexpected Color | 2 | Device |
| 2023 | Patient-Device Incompatibility | 12 | Device |
| 2023 | Optical Problem | 28 | Device |
| 2023 | Off-Label Use | 368 | Device |
| 2023 | No Apparent Adverse Event | 188 | Device |
| 2023 | Misfocusing | 164 | Device |
| 2023 | Material Opacification | 1 | Device |
| 2023 | Inadequacy of Device Shape and/or Size | 754 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 6 | Device |
| 2023 | Device Dislodged or Dislocated | 93 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 166 | Device |
| 2022 | Visual Disturbances | 4 | Patient |
| 2022 | Intraocular Pressure Increased | 4 | Patient |
| 2022 | Headache | 2 | Patient |
| 2022 | Halo | 5 | Patient |
| 2022 | Glaucoma | 1 | Patient |
| 2022 | Dizziness | 2 | Patient |
| 2022 | Corneal Edema | 1 | Patient |
| 2022 | Cataract | 3 | Patient |
| 2022 | Blurred Vision | 31 | Patient |
| 2022 | Appropriate Term / Code Not Available | 13 | Patient |
| 2022 | Unintended Movement | 15 | Device |
| 2022 | Patient-Device Incompatibility | 6 | Device |
| 2022 | Patient Device Interaction Problem | 2 | Device |
| 2022 | Optical Problem | 27 | Device |
| 2022 | Off-Label Use | 279 | Device |
| 2022 | No Apparent Adverse Event | 120 | Device |
| 2022 | Misfocusing | 104 | Device |
| 2022 | Inadequacy of Device Shape and/or Size | 551 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 4 | Device |
| 2022 | Device Dislodged or Dislocated | 76 | Device |
| 2022 | Appropriate Term/Code Not Available | 4 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 65 | Device |
| 2021 | Blurred Vision | 2 | Patient |
| 2021 | Appropriate Term / Code Not Available | 2 | Patient |
| 2021 | Optical Problem | 2 | Device |
| 2021 | Off-Label Use | 33 | Device |
| 2021 | No Apparent Adverse Event | 3 | Device |
| 2021 | Misfocusing | 14 | Device |
| 2021 | Inadequacy of Device Shape and/or Size | 73 | Device |
| 2021 | Device Dislodged or Dislocated | 14 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2020 | Patient-Device Incompatibility | 1 | Device |
| 2020 | Optical Distortion | 1 | Device |
| 2020 | Off-Label Use | 1 | Device |
| 2020 | No Apparent Adverse Event | 1 | Device |
| 2020 | Inadequacy of Device Shape and/or Size | 3 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |