MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2013-03-28 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[22041522]
Pt reported after rinsing and storing lenses overnight in solution, the lenses appeared misshapen and upon insertion both eyes began to burn. Pt who is an emergency room nurse self diagnosed as having a chemical burn and self treated with over the counter antihistamine drops and anti-inflammatory drops. Pt also experienced light sensitivity and decided to seek medical attention. Medical documentation rec'd noted pt had chemical keratitis and iritis in both eyes. Doctor cannot determine the exact cause of the event. Pt was treated with blephamide and condition has resolved.
Patient Sequence No: 1, Text Type: D, B5
[22360742]
The product was returned for evaluation, however, the complaint sample was insufficient to perform all testing. Preliminary evaluation results of the testing performed found the solution met chemical specifications; preservative and microbiology testing is in progress. Based on all available info, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2013-00002 |
| MDR Report Key | 3037649 |
| Report Source | 04,05 |
| Date Received | 2013-03-28 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-02-26 |
| Date Mfgr Received | 2013-03-19 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLENE MARTRANO |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388995 |
| Manufacturer G1 | BAUSCH & LOMB |
| Manufacturer Street | 8507 PELHAM RD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU FRESH MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2013-03-28 |
| Returned To Mfg | 2013-03-19 |
| Lot Number | GJ2005 |
| Device Expiration Date | 2014-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-28 |