BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LIFESTYLE MV2 MULTIFOCAL CONTACT LENS

    MDR report key: 198212 · Received November 19, 1998

    Report

    Report Number
    2249258-1998-00001
    Event Type
    Injury
    Date Received
    November 19, 1998
    Date of Event
    October 19, 1998
    Report Date
    November 18, 1998
    Manufacturer
    THE LIFESTYLE CO., INC.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 10/19/98, CO'S CUSTOMER SVC DEP REC'D A COMPLAINT FROM DR'S TECHNICIAN, THAT WAS DETERMINED TO BE A POTENTIAL ADVERSE INCIDENT. SOURCE REPORTED THAT ONE OF CO'S MV2 CONTACT LENSES HAS STUCK TO PT'S EYE WHEN THE PT WAS BEING FITTED WITH THE LENS BY DR. ACCORDING TO THE REPORT, WHEN DR REMOVED THE LENS, HE FOUND THAT PT HAS SUFFERED A SMALL CORNEAL ABRASION THAT INVOLVED SEVERAL LAYERS OF THE CORNEAL EPITHELIUM. THE PT WAS TREATED WITH OCUFLOX AND A CREAM WITHOUT FURTHER COMPLICATION.

    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 8-1201-3803-104

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention 1. LENS ORDER DATE: 10/08/98.| 2. LENS SHIP DATE: 10/08/98.