BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LIFESTYLE GP MULTIFOCAL CONTACT LENS

    MDR report key: 235614 · Received August 12, 1999

    Report

    Report Number
    2249258-1999-00001
    Event Type
    Injury
    Date Received
    August 12, 1999
    Date of Event
    July 7, 1999
    Report Date
    August 12, 1999
    Manufacturer
    THE LIFESTYLE CO, INC.
    Product Code
    HQD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON JULY 12, 1999, THE CO'S CUSTOMER SVC DEPT REC'D A COMPLAINT THAT ONE OF ITS GP LENSES BROKE IN PT'S RIGHT EYE ON JULY 7. PT REPORTED TO HIS FITTING TECH AT DR'S, CLINIC THAT UPON INSERTING THE LENS IT HAD FELT AS IF IT HAD DECENTERED. WHEN THE PT TRIED TO CENTER THE LENS, THE PT REPORTED THAT THE LENS BROKE AND SCRATCHED HIS EYE. THE PT WAS TREATED AT THE EMERGENCY ROOM AND WAS DIAGNOSED WITH CENTRAL CORNEAL ABRASION WITH STIPLING. SEVERAL LENS PIECES WERE REMOVED FROM THE PT'S EYE AT THE E.R. AS REPORTED BY THE TECH. THE PT WAS GIVEN DYLATIN DROPS AND ANTIBIOTICS ALONG WITH AN EYE PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LIFESTYLE GP MULTIFOCAL CONTACT LENS RIGID GAS PERMEABLE HYDROPHOBIC CONTACT LENS HQD THE LIFESTYLE CO, INC. LIFESTYLE GP WORK IN PROGRESS (WIP#) D3O

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention 1. LENS ORDER DATE, 4/14/99,| 3. LENS RELEASE DATE: 4/14/99.| 2. LENS MANUFACTURE DATE: 4/14/99,