FDA Adverse Event
Injury
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1944393
·
Received December 22, 2010
Report
- Report Number
- 2023826-2010-01291
- Event Type
- Injury
- Date Received
- December 22, 2010
- Date of Event
- December 13, 2010
- Report Date
- December 14, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL: METHOD - (OTHER) -LENS WORK ORDER SEARCH. RESULTS: (OTHER) - A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN) - BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND BOTH HAPTICS TORN, WITH PIECES TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID.
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PIECE LENS AND THE LENS TORE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER SAME MODEL LENS WAS IMPLANTED. SUTURES WERE NOT REQUIRED.
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. | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | CARTRIDGE: MODEL NANOPOINT - LOT NUMBER UNK| INJECTOR: MODEL NANOPOINT - LOT NUMBER UNK| CARTRIDGE: MODEL NANOPOINT - LOT NUMBER UNK| INJECTOR: MODEL NANOPOINT - LOT NUMBER UNK |