FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1353611
·
Received March 26, 2009
Report
- Report Number
- 2023826-2009-00311
- Event Type
- Other
- Date Received
- March 26, 2009
- Date of Event
- February 25, 2009
- Report Date
- February 26, 2009
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO COMPLAINT AGAINST THE LENS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4204VL SILICONE PLATE LENS AND DID NOT LIKE THE WAY IT FIT IN THE EYE. THE LENS WAS REMOVED AND THREE PIECE LENS WAS IMPLANTED WITHOUT ANY PT INJURY. THE REPORTER STATED THE PT'S CAPSULE WAS NOT DAMAGED AND THERE WAS NOT A PROBLEM WITH THE LENS BUT A SURGEON'S PREFERENCES.
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 CO. | AA4204VL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | CARTRIDGE MODEL MTC-60CFP| STAARVISC II| INJECTOR MODEL MSI-TR |