FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 258044
·
Received January 5, 2000
Report
- Report Number
- 1119421-2000-00007
- Event Type
- Other
- Date Received
- January 5, 2000
- Date of Event
- November 24, 1999
- Report Date
- December 7, 1999
- Manufacturer
- ALCON LABORATORIES
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A SURGEON REPORTED THAT A PT COMPLAINS OF FLASHES OF LIGHT FROM THE SIDE, SIX MONTHS POST CATARACT SURGERY AND INTRAOCULAR LENS IMPLANT. IT WAS REPORTED THAT THIS PT HAS A LARGE EYE, A LARGE CAPSULAR BAG AND LOOSE ZONULES.
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 | 58 YR | Other |