BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIRON PHACO TIP 15 DEGREES

    MDR report key: 35465 · Received July 1, 1996

    Report

    Report Number
    35465
    Event Type
    Malfunction
    Date Received
    July 1, 1996
    Report Date
    July 1, 1996
    Manufacturer
    CHIRON VISION CORP
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A PHACOEMULSIFICATION OF CATARACT AND PLACEMENT OF POSTERIOR CHAMBER IMPLANT, THE SURGEON TOUCHED THE CAPSULE WITH THE DEVICE TIP WITHOUT PHACO. THIS RESULTED IN AN IMMEDIATE SMALL TEAR IN THE POSTERIOR CAPSULE THAT ENLARGED. TO REPAIR THIS A MINIMAL ANTERIOR VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIRON PHACO TIP 15 DEGREES PHACO TIP 15 DEGREES HQC CHIRON VISION CORP USTV15 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *