FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1202143
·
Received October 16, 2008
Report
- Report Number
- 2023826-2008-01304
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 25, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P900048
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A SILICONE THREE PIECE LENS, BUT THE LENS BECAME STUCK IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT.
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 | CARTRIDGE: MODEL AQ CARTRIDGE-FP| INJECTOR: MODEL MSI-TM |