BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHACO EMULSIFIER ASPIRATOR

    MDR report key: 12281 · Received January 31, 1994

    Report

    Report Number
    12281
    Event Type
    Other
    Date Received
    January 31, 1994
    Date of Event
    December 22, 1993
    Report Date
    January 5, 1994
    Manufacturer
    ALCON SURGICAL
    Product Code
    HQC
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POWER SURGED TO MAX SETTING WITHOUT INCREASING PRESSURE ON FOOT PEDAL. MAX POWER REACHED INSTANTLY WHEN FOOT PEDAL LIGHTLY DEPRESSED, CAUSING MORE EXTENSIVE EMULSIFICATION THEN DESIRED DURING CATARACT REMOVAL AND INTRAOCULAR LENS IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACO EMULSIFIER ASPIRATOR SURGICAL HQC ALCON SURGICAL 9001

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other