MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for CRYSTALENS ASPHERIC AT52A0-1600 manufactured by Bausch And Lomb Inc.
[138018757]
Had loss of close vision immediately after crystalens was implanted. Several yag treatments didn? T help. Now have difficulty driving and need glasses. Night driving is hard due to halos and starbursts. Paid (b)(6) to get a lens that was misleading and caused vision to be compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084666 |
| MDR Report Key | 8394134 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-04 |
| Date of Event | 2008-02-08 |
| Date Added to Maude | 2019-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYSTALENS ASPHERIC |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2019-03-05 |
| Model Number | AT52A0-1600 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH AND LOMB INC |
| Brand Name | CRYSTALENS ASPHERIC |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2019-03-05 |
| Model Number | AT50A0-1700 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH AND LOMB INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-05 |