MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2013-04-22 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[20652268]
Pt reported cleaning the lens and inserting it into the eye. After approx ten mins, the eye began to burn and turn red. The lens was removed and cleaned again. After re-inserting the lens, the pt experienced pain. The lens was removed overnight, irritation persisted and the pt sought medical attention. According to the pt, he was diagnosed with an infection, corneal abrasion, and two corneal ulcers in his right eye resulting in temporary vision loss, nerve damage, and antibiotic treatment. The pt reports the condition is 75% resolved, but has slight blurriness around the edges of vision. There is no f/u appointment scheduled. Pt claims the solution was tested by a lab and the results show a type of bacteria. The pt has not received the written lab report. The pt has been requested to provide a copy of the lab results. Medical documentation has not been received.
Patient Sequence No: 1, Text Type: D, B5
[20866873]
The product was not returned for eval. A review of the lot batch records and chemical testing of the retain sample showed all requirements were met. Medical info was not received. 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 | 1313525-2013-00004 |
| MDR Report Key | 3082887 |
| Report Source | 00,04 |
| Date Received | 2013-04-22 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2013-03-25 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2013-04-30 |
| 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 | 2013-04-22 |
| Lot Number | GD2081 |
| Device Expiration Date | 2014-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-04-22 |