FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 277824
·
Received May 12, 2000
Report
- Report Number
- 1119421-2000-00429
- Event Type
- Other
- Date Received
- May 12, 2000
- Report Date
- April 12, 2000
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A SURGEON REPORTED THAT A PT DESCRIBES SEEING LIGHT AND DARK AREAS GENERATED BY LIGHT SOURCES ENTERING TEMPORALLY. THE ASSOCIATION BETWEEN THIS EVENT AND THE INTRAOCULAR LENS (IOL) IS NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. | MA30BA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |