FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER 3 PIECE FOLDABLE INTRAOCULAR LE
MDR report key: 1952668
·
Received January 4, 2011
Report
- Report Number
- 2023826-2011-00001
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 8, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - LENS WORK ORDER SEARCH. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND HAPTIC BENT. LENS WAS RETURNED IN VIAL AND IN LIQUID. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THERE WAS AN ATTEMPT TO USE A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE TECH FOUND THE HAPTIC WAS TWISTED PRIOR TO LOADING THE LENS. STATED LENS WAS RECEIVED DAMAGED/DEFECTIVE. THERE WAS NO PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER 3 PIECE FOLDABLE INTRAOCULAR LE | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | INJECTOR MODEL UNK, LOT NUMBER UNK| CARTRIDGE MODEL UNK, LOT NUMBER UNK |