FDA Adverse Event
Injury
Summary report: N
RENUE WITH MOISTURELOC MULTI-PURPOSE SOLUTION
MDR report key: 697161
·
Received April 7, 2006
Report
- Report Number
- 1313525-2006-00009
- Event Type
- Injury
- Date Received
- April 7, 2006
- Date of Event
- May 1, 2005
- Report Date
- February 16, 2006
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- LYL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE MINISTRY OF HEALTH (MOH) REPORTED THAT A REVIEW OF CASES BETWEEN MAY 2005 AND FEBRUARY 2006 IDENTIFIED 39 EVENTS OF FUSARIUM KERATITIS. OF THE 39 REPORTED EVENTS, 34 PATIENTS REPORTED TO HAVE USED BAUSCH & LOMB RENU CONTACT LENS SOLUTION BEFORE THEIR SYMPTOM ONSET. SUBSEQUENT INFORMATION RECEIVED FROM THE MOH ON 3/30/06 INDICATED THERE ARE A TOTAL OF 69 CASES OF WHICH 60 PATIENTS ALLEGEDLY WERE USING A RENUE SOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENUE WITH MOISTURELOC MULTI-PURPOSE SOLUTION | MULTI-PURPOSE SOLUTION FOR SOFT CONTACT LENSES | LYL | BAUSCH & LOMB, INC. | NA | GF5018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |