FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1031385
·
Received April 18, 2008
Report
- Report Number
- 2023826-2008-00559
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- March 7, 2007
- Report Date
- March 25, 2008
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: 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 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 IN THE INJECTOR AND THE LENS TORE SO THE SURGEON OPTED NOT TO USE THE LENS, NO PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA | INTRAOCULAR LENS | HQL | STAAR SURGICAL | CQ2015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR MODEL: MSI-TM LOT NUMBER: UNK| CARTRIDGE MODEL CQ CARTRIDGE - FP-LOT NUMBER UNK| VISCOELASTIC: STAARVISC II LOT NUMBER: UNK |