FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1063775
·
Received June 19, 2008
Report
- Report Number
- 2023826-2008-00831
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 22, 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
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY MANUFACTURER. NO LENS RETURNED IN UNIT CARTON.
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED AND REMOVED A CC4204BF COLLAMER SINGLE PIECE LENS. ADD'L INFO HAS BEEN REQUESTED FROM THE FACILITY, BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS IS ONE OF TWO LENSES USED FOR THIS PT - SEE MFR REPORT #2023826-2008-00830.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | CC4204BF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | FOAM TIP PLUNGER MODEL AND LOT#UNK| CARTRIDGE MODEL AND LOT# UNK| INJECTOR MODEL AND LOT#UNK |