FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 274022
·
Received April 12, 2000
Report
- Report Number
- 1119421-2000-00343
- 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 Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A CONSUMER CALLED TO REPORT THAT CONSUMER IS EXPERIENCING WHAT CONSUMER DESCRIBES AS MOVEMENT (OSCILLATION, QUIVERING) OF CONSUMER'S INTRAOCULAR LENS (IOL) FOLLOWING CATARACT SURGERY RESULTING IN VISUAL SHIMMERINGS. MORE INFO IS BEING SOUGHT FROM THE IMPLANTING SURGEON.
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 |