FDA Adverse Event
Malfunction
Summary report: N
MICROSTAAR INJECTOR
MDR report key: 1120025
·
Received August 14, 2008
Report
- Report Number
- 2023826-2008-01075
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 15, 2008
- Report Date
- July 24, 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
- SF
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A 24.0 SE/2.0 DIOPTER TORIC SILICONE SINGLE PIECE LENS BUT THE LENS TORE IN THE INJECTOR. THERE WAS NO PT CONTACT OR INJURY. A DIFFERENT TYPE LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE TORN LENS WAS DUE TO THE INJECTOR OR CARTRIDGE. THE PT'S CURRENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSTAAR INJECTOR | INTRAOCULAR LENS GUIDE | KYB | STAAR SURGICAL CO. | MSI-PR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | LENS: MODEL AA4203TF| CARTRIDGE: MODEL MTC-60C FP - LOT #1192506 |