BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORRECTIVE EYEGLASS LENSES

    MDR report key: 4541679 · Received February 13, 2015

    Report

    Report Number
    MW5040887
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS COMPLAINT IS FOR (B)(6) NOT FOLLOWING 21 CFR 820. SINCE ORDERING NEW GLASSES ON (B)(6) 2014, THE LAB HAS MANUFACTURED AND SENT GLASSES AT LEAST 3 TIMES WHERE THE PRESCRIPTIONS ARE NOT CORRECT. AS OF (B)(6) 2015, I STILL HAVE NOT RECEIVED LENSES WITH THE CORRECT PRESCRIPTION. I DO NOT UNDERSTAND HOW THE LAB'S QUALITY SYSTEMS ARE NOT ABLE TO CATCH THAT LENSES ARE BEING MANUFACTURED WITH THE INCORRECT PRESCRIPTION AND THESE LENSES ARE BEING SENT TO CUSTOMERS. MY EYE DOCTOR CAUGHT THE MISTAKE AT LEAST TWICE THAT I'M AWARE OF AND I NOTICED IT ONCE AND HAD TO SEND THE LENSES BACK TO BE REMANUFACTURED. MY EYE DOCTOR OFFICE THAT MAY HAVE MORE INFO IS (B)(6). I HAVE 15 YEARS WORKING IN THE (B)(6) SYSTEMS. I BELIEVE THAT MY EXPECTATIONS FOR THIS DEVICE MANUFACTURE ARE ALIGNED WITH 21 CFR 820. ON (B)(6) 2014, LENSES WERE RETURNED TO THE LAB BECAUSE PRISM WAS LEFT OUT OF THE LENSES. ON (B)(6) 2015, LENSES WERE RETURNED TO THE LAB BECAUSE THERE WAS INCORRECT PRISM IN LENSES. ON (B)(6) 2015, LENSES WERE RETURNED TO THE LAB BECAUSE PRISM WAS LEFT OUT OF THE LENSES: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108033 CORRECTIVE EYEGLASS LENSES LENSES HQG

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other