FDA Adverse Event
Malfunction
Summary report: N
MICROSTAAR INJECTOR CARTRIDGE
MDR report key: 692110
·
Received March 23, 2006
Report
- Report Number
- 2023826-2006-00378
- Event Type
- Malfunction
- Date Received
- March 23, 2006
- Date of Event
- February 6, 2006
- Report Date
- February 21, 2006
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- KYB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT THE SURGEON WAS LOADING OR ADVANCING A COMPETITOR'S LENS IN A SFC-25 FP CARTRIDGE, PRIOR TO INSERTION AND THE SURGEON NOTICED THE LENS WAS GETTING DAMAGED. THE REPORTER STATED THAT THE CAUSE OF THE LENS TEAR WAS DUE TO THE SFC-25 FP CARTRIDGE. NO PATIENT CONTACT OR INJURY. THIS IS ONE OF TWOINCIDENTS FOR THE SAME PATIENT. SEE MANUFACTURER REPORT NUMBER 2023826-2006-00376, FOR THE SECOND INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSTAAR INJECTOR CARTRIDGE | INTRAOCULAR LENS FOLDERS AND INJECTORS | KYB | STAAR SURGICAL CO. | SFC-25 FP | 1200707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |