BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBBLE CONTACT LENSE

    MDR report key: 6885787 · Received September 22, 2017

    Report

    Report Number
    MW5072284
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    September 19, 2017
    Report Date
    September 20, 2017
    Manufacturer
    VISION PATH INCORPORATED
    Product Code
    MVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I PRESCRIBED THE PT CONTACT LENSES OF THE MATERIAL ETAFILCON A. SHAPE PARAMETERS WERE BASE CURVE 8.5 WITH A DIAMETER OF 14.2MM. PRESCRIPTION WAS FRAUDULENTLY FILLED BY (B)(4), (ALSO KNOWN AS (B)(4) CONTACTS). (B)(4)., DID NOT RECEIVE OR VERIFY THE PRESCRIPTION(B)(4) SENT THE PT CONTACT LENSES MADE FROM THE INCORRECT MATERIAL METHAFILCON A. THE SHAPE PARAMETER WAS ALSO INCORRECT WITH A BASE CURVE OF 8.6, ALTHOUGH THE DIAMETER OF THE LENS WAS THE SAME AT 14.2. CONTACT LENSES ARE MEDICAL DEVICES REGULATED BY THE FDA. IT IS ILLEGAL TO DISTRIBUTE CONTACT LENSES WITHOUT A VALID PRESCRIPTION. (B)(4) HAS PUT MY PT AT SERIOUS RISK OF INFECTION AND HYPOXIC CORNEAL COMPLICATIONS SUCH AS NEOVASCULARIZATION AND INFILTRATIVE KERATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667496 HUBBLE CONTACT LENSE HUBBLE CONTACT LENSES MVN VISION PATH INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention