FDA Adverse Event
Other
Summary report: N
POSTERIOR CHAMBER LENS
MDR report key: 430635
·
Received November 27, 2002
Report
- Report Number
- 1119421-2002-00467
- Event Type
- Other
- Date Received
- November 27, 2002
- Date of Event
- September 13, 2002
- Report Date
- October 28, 2002
- Manufacturer
- ALCON LABORATORIES, INC./HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ADDITIONAL INFO WAS PROVIDED BY THE REPORTING SURGEON. THE LENS WAS EXPLANTED ON 12/17/2002.
Description of Event or Problem · 1
A SURGEON REPORTS AN INTRAOCULAR LENS IMPLANTED IN 2000 WAS NOTED TO BE DISLOCATED TEMPORALLY. A LENS EXCHANGE IS BEING CONSIDERED. HOWEVER, NO DATE HAS BEEN IDENTIFIED. THE SURGEON FEELS THE LENS SIZE AND EROSION OF THE SUTURE WERE POSSIBLE CONTRIBUTING FACTORS IN THE LENS DISLOCATION. THE LABELING FOR THIS LENS DOES NOT INCLUDE THE USE OF SUTURE IN THE DIRECTIONS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSTERIOR CHAMBER LENS | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC./HUNTINGTON | CR5BU0 | 528096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |