FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE
MDR report key: 1052894
·
Received May 22, 2008
Report
- Report Number
- 2023826-2008-00703
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 30, 2008
- Report Date
- May 1, 2008
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVALUATION 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 ADVANCING A THREE PIECE COLLAMER LENS MODEL CQ2015, AND THE HAPTIC TORE IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE | INTRAOCULAR LENS | HQL | STAAR SURGICAL | CQ2015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | CARTRIDGE MODEL: CQ CATRIDGE-FP| INJECTOR MODEL: UNK |