FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1003346
·
Received February 27, 2008
Report
- Report Number
- 2023826-2008-00219
- Event Type
- Other
- Date Received
- February 27, 2008
- Date of Event
- January 29, 2008
- Report Date
- January 29, 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THERE WERE TEARS IN THE OPTIC AND A HAPTIC WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED A CQ2015A THREE PIECE COLLAMER LENS AND THE LENS TORE DURING INSERTION. THE LENS WAS CUT OUT OF THE EYE WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A TECHNICAL ERROR.
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 | UNK | CARTRIDGE MODEL CQ CARTRIDGE-FP| INJECTOR MODEL UNKNOWN |