MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2012-02-06 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[2437828]
Article reports a (b)(6) female presented with a red, painful left eye. Slit lamp exam found the eye to have epithelial defect, punctate staining, widespread corneal infiltrate, central hypopyon, and lid edema. Pt was diagnosed with contact lens related microbial keratitis with a high suspicion for acanthamoeba keratitis. The corneal signs were commensurate with acanthamoeba keratitis. Pt was admitted to hospital for ten days of intensive antimicrobial treatment. Two days before presentation, pt went swimming in a home pool, removed lenses while swimming and store them in a old storage case with unpreserved saline. Lenses were reinserted the next day. At (b)(6) exam, a diffuse central subepithelial scar remained, medication ceased and pt was discharged.
Patient Sequence No: 1, Text Type: D, B5
[9554029]
The product was not returned for evaluation. The lot number is unknown. The article noted two days prior to event, pt went swimming in a home pool, removed lenses while swimming and stored them in a old storage case with unpreserved saline. 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 | 1313525-2012-00004 |
| MDR Report Key | 2446008 |
| Report Source | 03,05 |
| Date Received | 2012-02-06 |
| Date of Report | 2012-02-02 |
| Date Mfgr Received | 2012-02-02 |
| Date Added to Maude | 2012-02-13 |
| 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 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 | 2012-02-06 |
| 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 | 2012-02-06 |