MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2011-05-23 for RENU MULTIPLUS MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[2135863]
Retailer reported that a consumer claims the solution caused contact lenses to turn cloudy. This complaint is recorded against a product lot that was recalled for a reported potential compromised package sterility concern. A recall (z-1026-2011) was completed in 2011 for this lot.
Patient Sequence No: 1, Text Type: D, B5
[9243713]
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. A recall (z-1026-2011) was completed in 2011 for this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2011-00010 |
| MDR Report Key | 2167831 |
| Report Source | 00,04 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-04-29 |
| Date Mfgr Received | 2011-04-29 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2011-08-17 |
| 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 | TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1026-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-05-23 |
| Lot Number | GH0078 |
| Device Expiration Date | 2012-08-31 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-23 |