FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1060887
·
Received June 13, 2008
Report
- Report Number
- 2023826-2008-00799
- Event Type
- Other
- Date Received
- June 13, 2008
- Date of Event
- May 5, 2008
- Report Date
- May 15, 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
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO COMPLAINT AGAINST THE LENS - RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE SURGEON INSERTED AN AQ2003V THREE PIECE SILICONE LENS AND THE PATIENT'S ANATOMY WAS UNABLE TO SUPPORT THE LENS. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY AND AN ACL WAS IMPLANTED. THE REPORTER STATED THAT THE INCIDENT WAS DUE A PRE-EXISTING PT CONDITION AND NOT RELATED TO THE LENS.
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. | AQ2003V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CARTRIDGE MODEL CQ CARTRIDGE-FP| INJECTOR MODEL MSI-TM |