FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1047863
·
Received May 8, 2008
Report
- Report Number
- 2023826-2008-00653
- Event Type
- Other
- Date Received
- May 8, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 15, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P900048
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THE HAPTIC OF AN AQ2010V SILICONE THREE PIECE LENS WAS TORN DURING LOADING BUT WAS NOT NOTICED UNTIL THE SURGEON HAD INSERTED THE LENS INTO THE PATIENT'S EYE. LENS WAS REMOVED WITH NO PT INJURY AND ANOTHER SILICONE THREE PIECE LENS WAS INSERTED. THIS LENS ALSO TORE - SEE MFR REPORT # 2023826-2008-00652. A THIRD SILICONE THREE PIECE LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE TORN LENS MAY HAVE BEEN DUE TO A LOADING ERROR.
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 | CARTRIDGE MODEL AQ CARTRIDGE-FP - LOT NUMBER UNK| INJECTOR MODEL MSI-TM - LOT NUMBER UNK |