FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 2002613
·
Received February 7, 2011
Report
- Report Number
- 2023826-2011-00101
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 26, 2011
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P900048
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS. LENS TORE DURING INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. A COMPETITOR'S LENS WAS IMPLANTED BECAUSE THEY DID NOT HAVE ANOTHER SAME MODEL AND SIZE LENS ON THEIR SHELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | AQ2010V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | INJECTOR: MODEL - MSI-TM, LOT NUMBER: UNK| VISCOELASTIC: MODEL- STAARVISC II, LOT NUMBER: UNK| CARTRIDGE: MODEL- AQ CARTRIDGE-FP, LOT NUMBER: UNK |