FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1002834
·
Received February 26, 2008
Report
- Report Number
- 2023826-2008-00253
- Event Type
- Other
- Date Received
- February 26, 2008
- Date of Event
- January 31, 2008
- Report Date
- January 31, 2008
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT EVALUATION SHOWS THE LENS HAS A HAPTIC TORN OFF AND A PIECE OF THE OPTIC IS TORN OFF AND MISSING. THE OTHER HAPTIC IS DEFORMED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE SURGEON WAS INSERTING A ASPHERIC THREE PIECE LENS MODEL CQ2015A AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. IT WAS REPORTED THAT THE LENS WAS DAMAGED DURING LOADING.
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 | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CARTRIDGE MODEL: CQ CARTRIDGE-FP LOT NUMBER: UNK| INJECTOR MODEL: MSI-TM LOT NUMBER: UNK |