FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 886440
·
Received July 26, 2007
Report
- Report Number
- 2023826-2007-01288
- Event Type
- Other
- Date Received
- July 26, 2007
- Date of Event
- April 24, 2007
- Report Date
- June 28, 2007
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND.
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS IN THE PT'S RIGHT EYE (OD). THE SURGEON PIGGY-BACKED AN AQ2003V SILICONE THREE PIECE LENS ONTO THIS LENS DURING THE SAME SURGERY. THE PT EXPERIENCED A REFRACTIVE SURPRISE. THE LENSES REMAIN IMPLANTED. SEE MFR REPORT #2023826-2007-01289 FOR THE SECOND LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | AA4203TL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | LENS MODEL AQ2003V| INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK |