FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1064022
·
Received June 19, 2008
Report
- Report Number
- 2023826-2008-00839
- Event Type
- Other
- Date Received
- June 19, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 28, 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
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A OPTIC WAS TORN AND THERE WAS CLEAR SURGICAL RESIDUE ON THE LENS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ5010V SILICONE THREE PIECE LENS AND A HAPTIC WAS TORN DURING INSERTION. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THAT THE INCIDENT WAS DUE TO THE SURGEON'S TECHNIQUE AND NOT RELATED TO THE LENS. THIS IS ONE OF TWO LENSES THE SURGEON ATTEMPTED TO IMPLANT IN THIS PATIENT. SEE MFR REPORT #2023826-2008-00838.
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. | AQ5010V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INJECTOR MODEL MST-TM| CARTRIDGE MODEL AQ CARTRIDGE-FP |