BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALDO CONTACTS

    MDR report key: 15282801 · Received August 23, 2022

    Report

    Report Number
    MW5111671
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    August 19, 2022
    Report Date
    August 19, 2022
    Manufacturer
    AINSLY LTD / PEGAVISION CORPORATION-DAXI
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I HAVE A PATIENT ALMOST BLIND FROM WALDO CONTACT LENS PRESCRIPTION. I PRESCRIBED ONE BRAND BUT HE SAW AN AD ONLINE FOR ANOTHER BRAND AND BOUGHT WALDO CONTACTS. HE HAS SEVERE CORNEA DAMAGE/ SCARRING/HAZINESS AND BLOOD VESSEL NEOVASCULARIZATION THRU THE CORNEA BECAUSE THEIR CONTACTS DON'T LET OXYGEN THROUGH. HE SAID HE SHOWED WALDO THE PRESCRIPTION FOR BIOFINITY BUT THEY SENT HIM WALDO CONTACTS. THERE IS NO CONSUMER PROTECTION FROM THESE COMPANIES THAT SWITCH ONE CONTACT TO THEIR BRAND THAT ISN'T GOOD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346941 WALDO CONTACTS LENSES, SOFT CONTACT, DAILY WEAR LPL AINSLY LTD / PEGAVISION CORPORATION-DAXI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other