FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 280852
·
Received June 2, 2000
Report
- Report Number
- 1119421-2000-00504
- Event Type
- Other
- Date Received
- June 2, 2000
- Report Date
- May 4, 2000
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CONSUMER REPORTED SEEING HALOS AT NIGHT AND STRIPES OF LIGHT DURING THE DAY. THE ASSOCIATION BETWEEN THIS EVENT AND THE IOL IS NOT KNOWN. ADDITIONAL INFO HAS BEEN SOUGHT FROM THE IMPLANTING SURGEON.
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 | 47 YR | Other |