MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2012-06-21 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[19225472]
Doctor reported a study pt presented with redness, irritation, and foreign body sensation of the left eye. Examination revealed corneal infiltrates os>od and pt was treated with vigamox in the left eye. Lens wear was discontinued and pt was exited from the study. Pt returned for a post-study visit 9 days later and condition had resolved. Doctor noted a small (<1mm) non-visually significant anterior stromal scar that was within the central 4mm of the left cornea. The scar was not present prior to the study. Doctor was unable to determine the exact etiology as both the test lens and the solution were new to the pt. A culture was not performed as there was no suspicion of infection.
Patient Sequence No: 1, Text Type: D, B5
[19474388]
The product was returned for eval and results found the solution met chemical specs. There are no other complaints on the lot. Doctor was unable to determine the exact etiology as both the test lens and the solution were new to the pt. 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 | 1313525-2012-00016 |
| MDR Report Key | 2633797 |
| Report Source | 02,05 |
| Date Received | 2012-06-21 |
| Date of Report | 2012-05-21 |
| Date of Event | 2012-05-21 |
| Date Mfgr Received | 2012-05-30 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-07-05 |
| 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. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388995 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 5807 PELHAM ROAD |
| 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 | 2012-06-21 |
| Returned To Mfg | 2012-06-01 |
| Lot Number | GB2026 |
| Device Expiration Date | 2014-02-28 |
| 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 | 2012-06-21 |