FDA Adverse Event
Malfunction
Summary report: N
SUPER FUNNEL CARTRIDGE
MDR report key: 582745
·
Received March 10, 2005
Report
- Report Number
- 2023826-2005-00323
- Event Type
- Malfunction
- Date Received
- March 10, 2005
- Report Date
- February 11, 2005
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE FACILITY STATED THE SURGEON WAS HAVING DIFFICULTY WITH THE CARTRIDGES AND PLUNGERS IN THE INJECTOR. THE NOTATION ON THE PACKAGING INDICATED A TORN HAPTIC, BUT THE LENS WAS NOT RETURNED. THE FACILITY INDICATED THAT THEY HAD NO FURTHER INFORMATION REGARDING THE CARTRIDGES AND PLUNGERS THAT WERE RETURNED. IT IS UNKNOWN IF THE LENS HAD PATIENT CONTACT OR IF PT INJURY OCCURRED. THE FACILITY HAD RETURNED FOR FOAM TIP PLUNGERS AND THE LOT NUMBER WAS 1192424. ALSO, SIX SFC-25 CARTRIDGES, LOT NUMBER 1192597, WERE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER FUNNEL CARTRIDGE | IOL INJECTION CARTRIDGE | HQL | STAAR SURGICAL CO. | SFC-25 | 1192597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |