BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARR SURGICAL - THE WAVE PHACO EMULSIFIED SYSTEM

    MDR report key: 2971542 · Received June 25, 2007

    Report

    Report Number
    2971542
    Event Type
    Injury
    Date Received
    June 25, 2007
    Date of Event
    June 19, 2007
    Report Date
    June 21, 2007
    Manufacturer
    STARR SURGICAL
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, PT UNDERWENT ELECTIVE LEFT EYE CATARACT REMOVAL AND LENS REPLACEMENT. DURING THE PHACO REMOVAL OF THE CATARACT, THE STARR PHACO EMULSIFIER POSSIBLY MALFUNCTIONED. THE IRRIGATION AND ASPIRATION HANDPIECE HAD ENTRAPPED THE CAPSULE AND WOULD NOT RELEASE. THE PT EXPERIENCED A CAPSULAR TEAR WITH NO VITREOUS LOSS. VITRECTOMY WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARR SURGICAL - THE WAVE PHACO EMULSIFIED SYSTEM PHACO EMULSIFIER HQC STARR SURGICAL NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other