BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE LIFESTYLE MV2 MULTIFOCAL CONTACT LENS

    MDR report key: 202707 · Received December 17, 1998

    Report

    Report Number
    2249258-1998-00003
    Event Type
    Other
    Date Received
    December 17, 1998
    Date of Event
    November 11, 1998
    Report Date
    December 17, 1998
    Manufacturer
    THE LIFESTYLE CO., INC.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 11, 1998, CO'S CUSTOMER SERVICE DEPARTMENT RECEIVED A COMPLAINT FROM DR. OFFICE THAT PATIENT HAD SUFFERED AN EYE INFECTION AFTER WEARING A PAIR OF MV2 LENSES. THE PATIENT, AFTER WEARING THE LENSES FOR ONE DAY WITH NO DISCOMFORT, EXPERIENCED A YELLOW-COLORED DISCHARGE AND BLURRED VISION FROM THE RIGHT EYE. THE PATIENT DISINFECTED THE LENSES IN AEOSEPT AND SWITCHED TO WEARING ANOTHER BRAND OF LENSES WITHOUT PROBLEM. CILOXAN WAS USED BY THE PATIENT TO TREAT THE INFECTION. THE PATIENT THEN TRIED THE ORIGINAL MV2 LENSES AGAIN AND THE INFECTION IN THE RIGHT EYE RESURFACED. THE PATIENT ALSO TRIED A SECOND PAIR OF MV2 LENSES THE WEEK OF DECEMBER 11TH. AT THE END OF THE DAY THE PATIENT EXPERIENCED THE SAME YELLOW DISCHARGE BUT FROM THE LEFT EYE. THE PATIENT'S WEARING OF THESE SAME LENSES AFTER DISINFECTING THEM ALSO CAUSED A RETURN OF DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LIFESTYLE MV2 MULTIFOCAL CONTACT LENS HYDROPHILIC CONTACT LENS LPL THE LIFESTYLE CO., INC. LIFESTYLE MV2 8-1202-4133-010

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention LENS RELEASE DATE: 9/3/98.| LENS MANUFACTURE DATE: 8/25/98.| LENS ORDER DATE: 10/8/98.