BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXLENS

    MDR report key: 9255466 · Received October 29, 2019

    Report

    Report Number
    MW5090773
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    February 20, 2019
    Report Date
    October 29, 2019
    Manufacturer
    X-CEL SPECIALTY CONTACTS
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER CALLED TO REPORT THAT ON HER SEVENTH EYE APPOINTMENT WITH (B)(6), OPHTHALMOLOGY TECH TO BE FITTED WITH SOFT CONTACT LENS; "WE WASHED OUR HAND THOROUGHLY AND PROCEEDED TO PLACE THE LENS IN MY EYE." "I HADN'T GOTTEN THE LENS ALL THE WAY IN MY EYE WHEN I BEGAN TO YELL IN PAIN." "I COULDN'T GET THE LENS IN MY EYE BECAUSE IT HURT TOO BAD." CALLER STATED THAT SHE HAD TEARING, BURNING SENSATION AND THAT SHE WAS AFRAID HER IRREGULAR CORNEA WOULD BE DAMAGED FURTHER BECAUSE OF THIS. THE CALLER'S EYE WAS FLUSHED THREE TIMES AND WAS GIVEN A COLD PACK. THE CALLER WAS UNABLE TO DRIVE HOME DUE TO PAIN AND SWELLING IN HER EYE. SHE CALLED HER HUSBAND TO TELL HIM ABOUT THE INCIDENT AND HE REQUESTED HER NOT TO DRIVE HOME. SHE SAT IN HER CAR FOR SEVERAL HOURS WITH SUNGLASSES ON. ONCE SHE WAS HOME SHE CONTINUED TO PUT AN ICE PACK ON HER EYE, AND NOTICED IN THE MIRROR THAT HER EYE WAS BLOOD SHOT RED. "I WANTED TO GET MY MEDICAL RECORDS AND LEARNED THAT THE TECH DID NOT KEEP RECORD OF ALL OF MY APPOINTMENTS NOR, DID MY OPHTHALMOLOGIST KNOW OF THE INCIDENT THAT HAPPENED TO ME DURING THOSE APPOINTMENTS WITH THE TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048323 FLEXLENS LENSES, SOFT CONTACT, DAILY WEAR LPL X-CEL SPECIALTY CONTACTS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention