MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-25 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2350 manufactured by Bausch + Lomb.
[186403301]
Additional information has been requested from the reporter, but has not been received. The lens was not returned for evaluation. The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates. No similar events have been reported for this product lot. Based on the information provided, we are unable to determine a root cause. Corrective action is not necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[186403302]
It was reported that an intraocular lens (iol) was explanted 3? Months post implant due to z factor mechanical complication. The lens was replaced with different model anterior chamber lens of a different diopter. Though requested, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00061 |
| MDR Report Key | 9878455 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-28 |
| Date of Event | 2018-12-21 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| 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 | 2020-03-25 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-2350 |
| Lot Number | 7569424 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |