MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-07 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2500 manufactured by Bausch + Lomb.
[135502089]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135502090]
It was reported that the lens was tilted asymmetrically in the left eye at time of implantation. Despite rotating and re-positioning, the lens remained tilted. Patient discomfort and pain made the removal and replacement of the lens unsafe during the initial procedure. The lens was then explanted approximately one month post-op and replaced with a different model lens. The patient's current prognosis is very good post exchange. In the physician's opinion the cause of the event is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00028 |
| MDR Report Key | 8318947 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-07 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-18 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2019-02-07 |
| 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. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33759 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYSTALENS ACCOMMODATING IOL |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2019-02-07 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-2500 |
| Lot Number | 7652314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |