FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 279812
·
Received May 24, 2000
Report
- Report Number
- 1119421-2000-00480
- Event Type
- Other
- Date Received
- May 24, 2000
- Report Date
- April 24, 2000
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A CONSUMER REPORTS HAVING EXPERIENCED GLARE AND SEE REFLECTIONS OF LIGHT FOLLOWING CATARACT SURGERY.
Description of Event or Problem · 1
THE SURGEON PROVIDED ADDITIONAL INFO STATING HE BELIEVES THE PT'S GLARE SYMPTOMS MAY BE RELATED TO DRY EYES RATHER THAN THE INTRAOCULAR LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. | MA60BM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |