FDA Adverse Event
Injury
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 3093633
·
Received May 1, 2013
Report
- Report Number
- 2023826-2013-00329
- Event Type
- Injury
- Date Received
- May 1, 2013
- Date of Event
- March 28, 2013
- Report Date
- April 24, 2013
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - INCISION SUTURED. (B)(4). EVALUATION 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): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, 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 CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS. PART OF THE FOOT PLATE RIPPED OFF UPON INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE IOL AND A SUTURE WAS REQUIRED. THE LENS WAS DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189259 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | INJECTOR MODEL - NANOPOINT - LOT # UNK| CARTRIDGE MODEL - NANOPOINT - LOT # UNK |