FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 280175
·
Received May 26, 2000
Report
- Report Number
- 1119421-2000-00483
- Event Type
- Other
- Date Received
- May 26, 2000
- Report Date
- April 27, 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 CALLED TO REPORT THAT, FOLLOWING CATARACT SURGERY, CONSUMER HAS BEEN EXPERIENCING BLURRY VISION IN REDUCED LIGHT OR DARKNESS. THE CONSULTING OPHTHALMOLOGIST PERFORMED A YAG LASER CAPSULOTOMY WITH NO RELIEF OF THE REPORTED SYMPTOMS. IT IS DR'S (CONSULTING OPHTHALMOLOGIST) OPINION THAT THE SYMPTOMS MAY BE ASSOCIATED WITH BLEEDING THAT OCCURRED AT THE TIME OF SURGERY WHICH SUBSEQUENTLY LODGED BETWEEN THE POSTERIOR CAPSULE AND THE INTRAOCULAR LENS ALLOWING A MONOLAYER OF RED BLOOD CELLS TO OCCUR. HOWEVER, THIS THEORY HAS NOT BEEN CONFIRMED.
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 | UNKNOWN | Other |