MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-11 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2050 manufactured by Bausch + Lomb.
| Report Number | 0001313525-2019-00156 |
| MDR Report Key | 9178838 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-11 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2016-01-18 |
| Date Added to Maude | 2019-10-11 |
| 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 | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 N PARK PL 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 | 2019-10-11 |
| Returned To Mfg | 2019-10-01 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-2050 |
| Lot Number | 7640509 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN ST. ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-11 |