BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIC LENS

    MDR report key: 48566 · Received November 11, 1996

    Report

    Report Number
    2023826-1996-90002
    Event Type
    Injury
    Date Received
    November 11, 1996
    Date of Event
    June 24, 1996
    Report Date
    October 15, 1996
    Manufacturer
    STARR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CATARACT SURGERY ON 6/24/96, AND IMPLANTATION OF INTRAOCULAR LENS WAS ATTEMPTED BY THE SURGEON. HOWEVER, THE SURGEON NOTICED THAT DURING INSERTION THE LENS EJECTED TOO QUICKLY CAUSING A POSTERIOR CAPSULE TEAR AND THE SURGEON SAID A VITRECTOMY WAS NECESSARY. THE SURGEON THEN IMPLANTED A THREE PIECE LENS AND THE PT IS DOING WELL, HER VISUAL ACUITY IS 20/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS Implant INTRAOCULAR LENS HQL STARR SURGICAL CO. AA-4203VF 104163

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention