FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 2080161
·
Received April 7, 2011
Report
- Report Number
- 2023826-2011-00279
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 18, 2011
- Report Date
- March 21, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON USED A (B)(4) TORIC OPTIC SILICONE SINGLE PIECE LENS. STATED THE LENS WAS INSERTED HALF WAY INTO THE EYE WHEN THE SURGEON NOTICED THE PLATE HAPTIC WAS TORN. SURGEON WAS ABLE TO PULL THE LENS OUT WITH THE LENS STILL IN THE CARTRIDGE. THERE WAS NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | AA4203TL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | INJECTOR: MODEL MSI-PR, LOT NUMBER UNK| CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER UNK |