FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 230369
·
Received July 1, 1999
Report
- Report Number
- 1119421-1999-01068
- Event Type
- Other
- Date Received
- July 1, 1999
- Report Date
- June 4, 1999
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A SURGEON REPORTS THAT A PT COMPLAINS OF SEEING WHITE LINES IN BOTH EYES. PT IS REPORTED TO BE HIGLY MYOPIC. A YAG WAS PERFORMED ON BOTH EYES WITHOUT IMPROVEMENT. CURRENT VISUAL ACUITY IS 20/20. THIS MEDWATCH IS FOR THE LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF Implant | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. | MA60BM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |