FDA Adverse Event
Malfunction
Summary report: N
INTREPID PLUS FMS KELMAN ABS
MDR report key: 3220894
·
Received June 27, 2013
Report
- Report Number
- 3220894
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 27, 2013
- Manufacturer
- ALCON RESEARCH, LTD
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
MD TRIED NEW INTREPID PLUS 45 DEGREE MINI FLARED TIP FOR CATARACT EXTRACTION WITH PHACOEMULSIFICATION AND IOL IMPLANT.MD NOTICED WOUND WAS BURNED AND LEAKING AFTER HE INSERTED THE LENS DUE TO NEW PHACO TIP AND MALFUNCTION OF PHACO - INFINITI MACHINE.THIS IS THE SECOND OCCURRENCE GENERATED REGARDING THIS ISSUE WITH THIS DEVICE.PRODUCT WAS BEING USED ON TRIAL BASIS. TRIAL WAS STOPPED AND PRODUCTS REMOVED FROM SERVICE.MANUFACTURER'S REPRESENTATIVE WAS IN OR DURING PROCEDURE(S).WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CATARACT REMOVAL AND IOL PLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291867 | INTREPID PLUS FMS KELMAN ABS | PHACOFRAGMENTATION SYSTEM, HANDPIECE | HQC | ALCON RESEARCH, LTD | * | * | |
| 291868 | MIN-FLARED ABS KELMAN | PHACOFRAGMENTATION SYSTEM, TIP | HQC | ALCON RESEARCH, LTD | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | INFINITI PHACOEMULSIFICATION SYSTEM |