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 2019-05-15 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-1850 manufactured by Bausch + Lomb.
[145213172]
The investigation is underway.
Patient Sequence No: 1, Text Type: N, H10
[145213173]
A patient experienced z syndrome in the right eye, leading to an explant on (b)(6) 2019. The doctor who performed the explant is not the doctor who performed the original procedure. Though requested, no additional information has been received from the implanting doctor or the explanting doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00081 |
| MDR Report Key | 8613122 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-08 |
| Device Manufacturer Date | 2016-05-20 |
| Date Added to Maude | 2019-05-15 |
| 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 | TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| 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 | 2019-05-15 |
| Returned To Mfg | 2019-05-21 |
| Model Number | AO1UV |
| Catalog Number | AO1UV-1850 |
| Lot Number | 7652602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-15 |