MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-30 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[2786720]
Doctor reported a pt presenting with eye pain in both eyes. Upon examination, pt was diagnosed and treated for corneal erosion. Three weeks later at a follow up visit, the corneal erosion was improved. The injury did not penetrate the bowman's membrane and there was no permanent decrease in visual acuity. There was a central corneal scar.
Patient Sequence No: 1, Text Type: D, B5
[9931802]
The product was returned for eval and results found the solution met chemical specifications. Doctor did not relate the event to a specific product. Based on all info, no causal factor can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2012-00013 |
| MDR Report Key | 2596733 |
| Report Source | 01,05 |
| Date Received | 2012-05-30 |
| Date of Report | 2012-04-27 |
| Date of Event | 2012-04-15 |
| Date Mfgr Received | 2012-05-21 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-06-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLENE MARTRANO |
| Manufacturer Street | 1400 NORTH GOODMAN ST GLOBAL PRODUCT SURVEILLANCE |
| 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 | 2012-05-30 |
| Returned To Mfg | 2012-05-16 |
| Lot Number | GE1134 |
| Device Expiration Date | 2013-05-31 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-30 |