FDA Adverse Event
Injury
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE
MDR report key: 709045
·
Received May 5, 2006
Report
- Report Number
- 2023826-2006-00583
- Event Type
- Injury
- Date Received
- May 5, 2006
- Date of Event
- April 5, 2006
- Report Date
- April 5, 2006
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE SURGEON INSERTED AN AQ2003V SILICONE THREE PIECE LENS AND THE CAPSULE WAS TORN. THE REPORTER WAS UNCERTAIN AS TO WHAT CAUSED THE TEAR. THIS THE THIRD LENS THE SURGEON ATTEMPT TO IMPLANT IN THIS PATIENT. THE LENS WAS REMOVED AND A FOURTH LENS WAS IMPLANTED. THE INCISION WAS SUTURED AND NO VITRECTOMY WAS PERFORMED. SEE MFR REPORT NUMBERS 2023826-2006-000581 AND 2023826-2006-000582.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | AQ2003V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |