FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 2970137
·
Received February 15, 2013
Report
- Report Number
- 2023826-2013-00130
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- August 16, 2012
- Report Date
- January 18, 2013
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL METHOD: - LENS WORK ORDER SEARCH. RESULTS: - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): THE PRODUCT PERTAINING TO THIS CLAIM WAS NOT RETURNED FOR EVAL. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. #(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON ATTEMPTED TO USE A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS. STATED LENS NOT EXITING SHOOTING DEVICE. THE LENS IS DEFECTIVE. THERE WAS NO PT CONTACT. THE LENS WAS DISCARDED. REPORTER STATED NO ADDITIONAL INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68628 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CARTRIDGE: MODEL - NANOPOINT LOT NUMBER UNK| INJECTOR: MODEL - NANOPOINT LOT NUMBER UNK |