BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIMIDE LENS

    MDR report key: 38809 · Received September 19, 1996

    Report

    Report Number
    2023826-1996-00025
    Event Type
    Injury
    Date Received
    September 19, 1996
    Date of Event
    August 20, 1996
    Report Date
    September 19, 1996
    Manufacturer
    STARR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CATARACT SURGERY ON 8/20/96, IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTED THAT THE LENS DID NOT EJECT IN A CONTROLLED MANNER, CAUSING IT TO FLIP OVER DURING INSERTION. THE SURGEON NOTICED A POSTERIOR CAPSULE TEAR PRIOR TO LENS INSERTION AND AN ANTERIOR VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIMIDE LENS Implant INTRAOCULAR LENS HQL STARR SURGICAL CO. AQ-2010V 1106020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention