FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 673458
·
Received February 2, 2006
Report
- Report Number
- 1119421-2006-00021
- Event Type
- Other
- Date Received
- February 2, 2006
- Date of Event
- November 10, 2005
- Report Date
- January 3, 2006
- Manufacturer
- ALCON LABORATORIES, INC./HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A SURGEON REPORTS A PATIENT HAS DESCRIBED SEEING DARK CIRCLES (AS IF HE IS SEEING THE EDGE OF THE LENS), FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC./HUNTINGTON | SA60AT | 910478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |