FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 274013
·
Received April 12, 2000
Report
- Report Number
- 1119421-2000-00344
- Event Type
- Other
- Date Received
- April 12, 2000
- Report Date
- March 13, 2000
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FOLLOWING INFO WAS RECEIVED IN A LETTER SUBMITTED BY A CONSUMER. FOLLOWING CATARACT SURGERY, A CONSUMER REPORTED EXPERIENCING STREAKS OF LIGHT COMING INTO CONSUMER'S VISION. THE STREAKS ARE MOST NOTICEABLE AT NIGHT WHEN ENCOUNTERING TRAFFIC OR STREET LIGHTS.
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 | UNKNOWN | Other |