BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM THIN HIGH ADD RGP MULTIFOCAL

    MDR report key: 1373506 · Received April 29, 2009

    Report

    Report Number
    1034196-2009-00001
    Event Type
    Injury
    Date Received
    April 29, 2009
    Report Date
    April 29, 2009
    Manufacturer
    UNILENS CORP., USA
    Product Code
    HPX
    PMA / PMN Number
    870024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL TESTED PARAMETERS MET INSPECTION/RELEASE CRITERIA FOR THE RETURNED LENS. IN THE COSMETIC EXAMINATION OF THE LENS SURFACES, A SMALL BURNISHED AREA WAS FOUND NEAR THE EDGE OF THE LENS THAT WAS WITHIN ACCEPTABLE CRITERIA AND WOULD NOT HAVE CAUSED THE NOTED ADVERSE EVENT.

    Description of Event or Problem · 1

    DOCUMENTATION RECEIVED WITH RETURNED PRODUCT INDICATED "THIS LENS IS DEFECTIVE. ABRASION 2009 REC'D NEW CL". THE FOLLOWING MONTH, THE ATTENDING HEALTHCARE PRACTITIONER RESPONDED TO QUERIES AND INDICATED THE ABRASION WAS NOTED AT THE TIME OF CONTACT LENS DISPENSING, WITH THE LENS BEING TOO UNCOMFORTABLE AND PAINFUL FOR THE PATIENT. PROPHYLACTIC ANTIBIOTICS WERE GIVEN. NO PROGNOSIS WAS GIVEN. THE PT IS NOT CURRENTLY WEARING A REPLACEMENT CONTACT LENS. NO SOLUTIONS WERE DISPENSED TO THE PT, AND THE PT IS USING A DEEP WELL SCREW TOP CONTACT LENS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM THIN HIGH ADD RGP MULTIFOCAL RIGID GAS PERMEABLE CONTACT LENS HPX UNILENS CORP., USA QUANTUM THIN 231093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other