BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LIFESTYLE XTRA MULTIFOCAL CONTACT LENS

    MDR report key: 171197 · Received June 5, 1998

    Report

    Report Number
    2434214-1998-00001
    Event Type
    Injury
    Date Received
    June 5, 1998
    Date of Event
    February 9, 1998
    Report Date
    May 22, 1998
    Manufacturer
    THE LIFESTYLE CO., INC.
    Product Code
    MFK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 2/9/98, CO'S CUSTOMER SVC DEPT REC'D A REPORT FROM A DR THAT PT DISPLAYED A CENTRAL CORNEAL ULCER AFTER WEARING A LIFESTYLE XTRA SOFT CONTACT LENS. PT HAD NO PREVIOUS PROBLEMS WITH ANY OTHER LENSES, ACCORDING TO THIS REPORT. ON 3/9/98, LIFESTYLE QUALITY CONTROL PERSONNEL, CONTACTED THE DR WHO SAID THE PT ACTUALLY HAD EXPERIENCED A MINOR ABRASION. THE DR DID NOT KNOW IF THE XTRA LENS HAD ANYTHING TO DO WITH THE ABRASION. THE DR FURTHER REPORTED THAT AS OF 2/16/98, PT'S EYE WAS COMPLETELY HEALED AND THE DR DISPENSED A NEW LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LIFESTYLE XTRA MULTIFOCAL CONTACT LENS HYDROPHILIC CONTACT LENS MFK THE LIFESTYLE CO., INC. XTRA MULTIFOCAL CONTACT LENS 711010281003

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention LENS SHIP DATE: 2/4/98.| LENS ORDER DATE: 2/4/98.