FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1061018
·
Received June 13, 2008
Report
- Report Number
- 2023826-2008-00805
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 20, 2008
- Report Date
- May 21, 2008
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LENS BOX WAS RECEIVED WITH NO LENS INSIDE. EVAL: CONCLUSIONS - A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVAL OF TEST RESULTS. ADDITIONALLY, THE INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE SURGEON WAS INSERTING A ONE PIECE SILICONE LENS MODEL AA4204VF AND THE LENS TORE AS IT WAS LEAVING THE INJECTOR, AND THERE WAS PT CONTACT BUT NO PT INJURY.
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 | AA4204VF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR: MODEL MSI-PR LOT#UNK| CATRIDGE: MODEL MTC-60CFP LOT#UNK |