FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 992377
·
Received February 7, 2008
Report
- Report Number
- 2023826-2008-00154
- Event Type
- Other
- Date Received
- February 7, 2008
- Date of Event
- September 5, 2007
- Report Date
- January 11, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT LENS WAS RECEIVED STUCK INSIDE ANOTHER MANUFACTURER'S CARTRIDGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO INSERT A CQ2015A THREE PIECE COLLAMER LENS AND A HAPTIC GOT CAUGHT WHILE ADVANCING IN THE CARTRIDGE. THERE WAS NO PT CONTACT. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR. THIS IS ONE OF TWO INCIDENTS INVOLVING THIS PT (SEE MFR REPORT # 023826-2008-00153).
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 CO. | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR MODEL UNK| CARTRIDGE MODEL UNK |