MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2012-04-30 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[2650474]
Literature article stated pt presented to the emergency department complaining of pain and redness in both eyes. Slit lamp examination revealed two infiltrates in the inferior part of the cornea in the right eye and five smaller infiltrates in the superior half of the left cornea. Pt was hospitalized for two days due to her anxiety of treating herself at home. Symptoms improved after hospitalization and treatment. At final follow up visit one week later, pt's condition resolved. A culture of the contact lens revealed serratia marcescens as the responsible infectious factor.
Patient Sequence No: 1, Text Type: D, B5
[9851499]
The product was not returned for evaluation. The lot number is unk. The article does not relate the event to a specific product but does reference the need for more detailed information to be provided to contact lens users concerning the prevention and management of potential complications. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2012-00012 |
| MDR Report Key | 2565449 |
| Report Source | 01,03,05 |
| Date Received | 2012-04-30 |
| Date of Report | 2012-04-26 |
| Date Mfgr Received | 2012-04-26 |
| Date Added to Maude | 2012-05-10 |
| 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 STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388995 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | VIA PASUBIO 34 MACHERIO |
| Manufacturer City | MILAN 20050 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 20050 |
| 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 | 2012-04-30 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-30 |