FDA Adverse Event
Injury
Summary report: N
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
MDR report key: 1140933
·
Received August 28, 2008
Report
- Report Number
- 1313525-2008-00029
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- January 1, 2007
- Report Date
- July 28, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- LPN
- PMA / PMN Number
- KO11796
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT AND LOT NUMBER ARE NOT AVAILABLE. NO MEDICAL DOCUMENTATION IS AVAILABLE. BASED ON AVAILABLE INFO, NO ROOT CAUSE CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
THE EVENT WAS REPORTED BY VISION CENTER AND THE PT WAS CONTACTED FOR INFO. THE PT REPORTED HAVING EYE INFECTIONS FROM 2005 TO 2007. THE PATIENT VISITED AN OPHTHALMOLOGIST IN 2007, WHO DIAGNOSED A CORNEAL ULCER AND REFERRED THE PT TO A CORNEAL SPECIALIST. THE PT REPORTS IN 2007, THE SPECIALIST DIAGNOSED ACANTHAMOEBA KERATITIS OF THE LEFT EYE. THE PATIENT RECOVERED WITH A RESIDUAL SCAR AND IS AWAITING A CORNEAL TRANSPLANT. THE PT HAS BEEN REQUESTED TO SIGN A MEDICAL RELEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | 86LPN | LPN | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ACUVUE II CONTACT LENSES |