BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONSI 56 GAS PERMEABLE CONTACT LENS

    MDR report key: 662179 · Received November 27, 2005

    Report

    Report Number
    MW1037608
    Event Type
    Other
    Date Received
    November 27, 2005
    Date of Event
    September 22, 2005
    Report Date
    November 27, 2005
    Manufacturer
    LAGADO CORPORATION
    Product Code
    HPX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RIGID GAS PERMEABLE CONTACT LENS COMPLICATION -- AFTER 9 MONTHS OF WEARING A NEW GENERATION CONTACT LENS IN ONE EYE, MOST UNUSUAL CRYSTALLINE DEPOSIT FORMED AT THE PERIPHERY AND MID-PERIPHERY OF THE LENS WHEREAS THE OTHER EYE, WEARING AN OLDER, CONVENTIONAL CONTACT LENS, UNDERWENT NO SUCH COMPLICATION. THE PT WAS USING BOSTON ADVANCE SOLUTIONS, AND THE NEW LENS. NO SUCH PHENOMENON HAS OCCURRED TO OTHER PTS WEARING THE ONSI-56, BUT ALL OF THEM ARE USING UNIQUE PH AS THEIR CLEANING AND DISINFECTING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONSI 56 GAS PERMEABLE CONTACT LENS RGP CONTACT LENS HPX LAGADO CORPORATION ONSI 56 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other