FDA Adverse Event
Injury
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 2051399
·
Received April 7, 2011
Report
- Report Number
- 2023826-2011-00301
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 24, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - INCISION SUTURED. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED AN AA4203TL TORIC OPTIC SILICONE SINGLE PIECE LENS. LENS TORE ON INSERTION INTO THE EYE. LENS WAS REMOVED WITH THE INCISION ENLARGED AND 3 TO 4 SUTURES. 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 | Required Intervention | CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER - UNK| INJECTOR: MODEL MSI-TR, LOT NUMBER - UNK |