FDA Adverse Event
Injury
Summary report: N
ACRYSOF
MDR report key: 220272
·
Received April 23, 1999
Report
- Report Number
- 1119421-1999-00595
- Event Type
- Injury
- Date Received
- April 23, 1999
- Date of Event
- March 5, 1999
- Report Date
- March 25, 1999
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INFORMATION PROVIDED BY THE SURGEON INDICATES THAT PT'S SYMPTOMS HAVE RESOLVED SINCE LENS WAS EXCHANGED ON 03/05/1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF Implant | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. | MA30BA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |