MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-08 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2150 manufactured by Bausch + Lomb.
[182775483]
Additional information has been requested, but has not been received. The lens remains implanted and therefore is not available for evaluation. The investigation is ongoing, additional information will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[182775484]
It was reported that the intraocular lens (iol) was tilted or there was possible z syndrome. Femtosecond laser was not used during the cataract surgery. The patient did not have any other post-operative issues. No post-op refractive error. The patient reported blurry vision postoperatively. The vaulting was first observed approximately one year prior to intervention. The patient was referred to a second surgeon for intervention; this surgeon was not the implanting physician. The surgeon re-positioned the lens. 1-day post-op after re-positioning, the patient is seeing 20/25 at distance, j5 for near. Patient? S current condition is -4. 00 +3. 25x1. 36. Additional information has been requested, but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00002 |
| MDR Report Key | 9566390 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-11-21 |
| Date of Event | 2018-12-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 PARK PLACE |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYSTALENS ACCOMMODATING IOL |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2020-01-08 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-2150 |
| Lot Number | 7649605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-01-08 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-08 |