FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCUAL
MDR report key: 1061020
·
Received June 13, 2008
Report
- Report Number
- 2023826-2008-00809
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 20, 2008
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 AN ASPHERIC THREE PIECE COLLAMER LENS MODEL CQ2015A AND A HAPTIC TORE. THE SURGEON REMOVED THE LENS WITH NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCUAL | INTRAOCULAR LENS | HQL | STAAR SURGICAL | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR: MODEL MSI-TM LOT#UNK| CARTRIDGE: MODEL CQ CARTRIDGE-FP LOT#UNK |