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 2019-03-19 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2400 manufactured by Bausch + Lomb.
[139243929]
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
[139243930]
It was reported that the back haptic of the lens broke off after insertion. The lens was removed and a back-up lens of the same model and diopter was implanted successfully. Allegedly, the lens was "breaking in pieces" when it was being removed. The incision was enlarged and standard protocol sutures were used. The patient's current prognosis is reported as stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00053 |
| MDR Report Key | 8433962 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-14 |
| Device Manufacturer Date | 2016-02-08 |
| Date Added to Maude | 2019-03-19 |
| 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 | 2019-03-19 |
| Returned To Mfg | 2019-02-27 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-2400 |
| Lot Number | 7641806 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-19 |