FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVILET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULA
MDR report key: 2516356
·
Received March 30, 2012
Report
- Report Number
- 2023826-2012-00223
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- February 28, 2012
- Report Date
- March 2, 2012
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECE OF PLATE HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. LENS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PLATE LENS. TORN, NOTED BY SURGEON, AFTER INSERTION INTO THE LEFT EYE. LENS WAS REMOVED WITH NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVILET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULA | INTROACULAR LENS | HQL | STAAR SURGICAL CO. | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | CARTRIDGE MODEL AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK |