FDA Adverse Event
Malfunction
Summary report: N
MICROSTAAR INJECTOR
MDR report key: 1083150
·
Received July 24, 2008
Report
- Report Number
- 2023826-2008-00979
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Report Date
- June 27, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- KYB
- PMA / PMN Number
- K954600
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON INSERTED A COMPETITOR'S LENS USING THE MSI-TR INJECTOR AND DISCOVERED A HAPTIC WAS BROKEN AFTER INSERTION. THE LENS WAS REMOVED WITHOUT ANY PT INJURY. THE RPTR STATED THE DAMAGE MAY HAVE BEEN CAUSED BY THE INJECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSTAAR INJECTOR | INTRAOCULAR LENS GUIDE | KYB | STAAR SURGICAL CO. | MSI-TR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | CARTRIDGE MODEL UNK |