BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACP-60A

    MDR report key: 478496 · Received August 15, 2003

    Report

    Report Number
    2027748-2003-00006
    Event Type
    Injury
    Date Received
    August 15, 2003
    Date of Event
    January 17, 2001
    Report Date
    August 4, 2003
    Manufacturer
    OPHTHALMIC INNOVATIONS INTL., INC.
    Product Code
    HQL
    Removal / Correction Number
    Z-869/871-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    OPHTHALMIC INNOVATIONS INTERNATIONAL RECEIVED A COURT SUMMONS FROM ATTORNEY IN 2001. THE SUMMONS STATES THAT THE PLAINTIFF WAS RENDERED SICK AND DISABLED, SUFFERED INJURIES, PAIN AND MENTAL ANGUISH, WAS COMPELLED TO SEEK MEDICAL CARE, INCURRED EXPENSES AND WAS PERMANENTLY INJURED AND DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACP-60A ANTERIOR CHAMBER PHAKIC IOL HQL OPHTHALMIC INNOVATIONS INTL., INC. ACP-60A 960315

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention