BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIC LENS

    MDR report key: 48543 · Received November 11, 1996

    Report

    Report Number
    2023826-1996-00028
    Event Type
    Injury
    Date Received
    November 11, 1996
    Date of Event
    October 8, 1996
    Report Date
    October 8, 1996
    Manufacturer
    STARR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD UNDERGONE CATARACT SURGERY ON 10/8/96, AND IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT THE CARTRIDGE HE USED HAD A "JUTTING OUT OF PLASTIC" AT THE END THAT HE FELT TORE THE ANTERIOR CAPSULE AND A VITRECTOMY WAS NECESSARY. THE SURGEON DISCARDED THE CARTRIDGE. THEREFORE, AN EVALUATION WAS NOT DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS Implant INTRAOCULAR LENS HQL STARR SURGICAL CO. AA-4203V 1105810

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention
    2