FDA Adverse Event
Injury
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1032344
·
Received April 22, 2008
Report
- Report Number
- 2023826-2008-00574
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- February 6, 2008
- Report Date
- March 28, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P900048
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE REPORTER STATED, THE SURGEON INSERTED AN AQ2010V SILICONE THREE PIECE LENS AND THE CAPSULE TORE. THERE WAS PT CONTACT BUT NO INJURY. SUTURES WERE REQUIRED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE FACILITY, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | AQ2010V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK |