FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1034594
·
Received April 24, 2008
Report
- Report Number
- 2023826-2008-00579
- Event Type
- Other
- Date Received
- April 24, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 2, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE RPTR STATED THE SURGEON INSERTED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME TYPE LENS WAS INSERTED, BUT THIS LENS ALSO TORE - SEE MFR REPORT #: 2023826-2008-00578. A THIRD LENS WAS IMPLANTED WITH NO PROBLEM. THE RPTR STATED THE CAUSE OF THE TORN LENS WAS DUE TO THE INJECTOR HAVING BEEN USED TOO MANY TIMES.
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 | CARTRIDGE MODEL MTC - 60C FP -LOT # UNK| INJECTOR MODEL MSI-PR - LOT # UNK |