BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LIFESTYLE GP MULTIFOCAL CONTACT LENS

    MDR report key: 171636 · Received June 8, 1998

    Report

    Report Number
    2434214-1998-00002
    Event Type
    Injury
    Date Received
    June 8, 1998
    Date of Event
    March 23, 1998
    Report Date
    June 5, 1998
    Manufacturer
    THE LIFESTYLE CO, INC.
    Product Code
    HQD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 3/23/1998, CUSTOMER SERVICE DEPARTMENT RECEIVED A REPORT FROM DR. WHO REPORTED THAT PT RETURNED TO HIS OFFICE AFTER WEARING NEW GP MULTIFOCAL CONTACT LENSES FOR ONE WEEK WITH A COMPLAINT OF A SERIOUS EYE INFECTION. DR. WENT ON TO REPORT THAT THE PT'S EYE WAS RED AND IRRITATED AND THAT THE PT THOUGHT IT WAS RELATED TO THE GP CONTACT LENS SHE WAS WEARING. THE DR SUSPECTED CHLAMYDIA AND REQUESTED INFO ABOUT CO'S DISINFECTING PROCESS. CO EXPLAINED TO THE DR THAT CO'S GP LENSES ARE SUPPLIED NONSTERILE AND SHOULD BE CLEANED AND CONDITIONED PRIOR TO USE. CO MADE SEVERAL ATTEMPTS TO CONTACT THE CONTACT LENS TECHNICIAN ABOUT THE RETURN OF THE LENS. THE LENS WAS RETURNED TO CO ACCOUNTING DEPARTMENT WITHOUT INDICATION OF ITS COMPLAINT STATUS ON 5/14/1998 AND CREDITED FOR A REFUND. THE LENS WAS PLACED IN TEMPORARY STORAGE BEFORE BEING DISCARDED. CO WAS ABLE TO LOCATE THE LENS ON 6/5/1998 AND PERFORM AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LIFESTYLE GP MULTIFOCAL CONTACT LENS RGP HYDROPHOBIC CONTACT LENS HQD THE LIFESTYLE CO, INC. GP MULTIFOCAL CONTACT LENS 2436397 (FOR SGP II MATERIAL)

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention LENS ORDER DATE: 2/16/1998.| LENS SHIP DATE: 2/18/1998.