FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 264404
·
Received February 16, 2000
Report
- Report Number
- 1119421-2000-00151
- Event Type
- Other
- Date Received
- February 16, 2000
- Report Date
- January 17, 2000
- Manufacturer
- ALCON LABORATORIES
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER REPORTS THAT AFTER CATARACT SURGERY AND INTRAOCULAR LENS (IOL) IMPLANT, EYE APPEARS TO BE LIKE A MIRROR WHEN OTHER PEOPLE LOOK AT IT.
Description of Event or Problem · 1
SURGEON DID NOT FEEL THE IOL MALFUNCTIONED. SURGEON FELT THE INCIDENT WOULD NOT CAUSE A SERIOUS INJURY IF WERE TO RECUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES | MA60BM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |