FDA Adverse Event
Malfunction
Summary report: N
SUPER FUNNEL CARTRIDGE
MDR report key: 582783
·
Received March 10, 2005
Report
- Report Number
- 2023826-2005-00324
- 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 THAT SURGEON WAS HAVING DIFFICULTY WITH THE CARTRIDGES AND PLUNGERS IN THE INJECTOR. THE NOTATION ON THE PACKAGE OF THE RETURNED PRODUCT INDICATED A TORN HAPTIC, BUT WITHOUT THE LENS. THE REGARDING THE CARTRIDGES AND PLUNGERS THAT WERE RETURNED. IT IS UNKNOWN IF THE LENS HAD PATIENT CONTACT OR IF PT INJURY OCCURRED. THE FACILITY RETURNED THREE SFC-25 CARTRIDGES, LOT NUMBER 1192713 AND THREE FOAM TIP PLUNGERS, LOT NUMBER 1192464.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER FUNNEL CARTRIDGE | IOL INJECTION CARTRIDGE | HQL | STAAR SURGICAL CO. | SFC-25 | 1192713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |