BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE LIFESTYLE GP MULTIFOCAL CONTACT LENS

    MDR report key: 184841 · Received August 26, 1998

    Report

    Report Number
    2434214-1998-00003
    Event Type
    Malfunction
    Date Received
    August 26, 1998
    Date of Event
    July 20, 1998
    Report Date
    August 25, 1998
    Manufacturer
    THE LIFESTYLE CO, INC.
    Product Code
    LPM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON JULY 20, 1998, LIFESTYLE CUSTOMER SVC REC'D A COMPLAINT OF A BROKEN GP CONTACT LENS FROM DR. A NEW LENS WAS REORDERED FOR THE PT. ON JULY 28, CO REC'D A RETURNED BROKEN LENS FROM DR. WITH A NOTE THAT STATED THAT THIS WAS THE SECOND TIME A LIFESTYLE GP LENS HAD BROKE IN PATIENT'S EYE. DR'S OFFICE CONTACTED THAT DAY (7/28) TO CONFIRM THAT A CONTACT LENS HAD BROKEN IN THE PT'S EYE. A FOLLOW-UP CONTACT ON 7/30/98 CONFIRMED THAT AN OS LENS (INVOICE # 816368) HAD BROKEN IN THE PT'S EYE A WEEK AFTER EXCESSIVE CLEANING TO REMOVE A CLOUDY SPOT. THE PT WAS ABLE TO REMOVE THE PIECES WITHOUT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THIS LENS WAS DISCARDED BY THE PT AND A NEW LENS WAS ORDERED AND SHIPPED ON 7/20/98 (INVOICE # 820670). THIS LENS ALSO BROKE, BUT NOT IN THE PT'S EYE, AND THIS LENS WAS RETURNED TO LIFESTYLE FOR ANALYSIS ON 7/28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LIFESTYLE GP MULTIFOCAL CONTACT LENS RGP HYDROPHOBIC CONTACT LENS LPM THE LIFESTYLE CO, INC. GP MULTIFOCAL CONTACT LENS 2409098, 2412598 (SGP II)

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other