FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1022252
·
Received March 26, 2008
Report
- Report Number
- 2023826-2008-00434
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 5, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED AND REMOVED AN AQ2003V SILICONE THREE PIECE LENS DURING THE SAME SURGERY AND ANOTHER SAME TYPE LENS WAS IMPLANTED WITH NO PROBLEM. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
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. | AQ2003V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK |