BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTACS CORNEAL IMPLANTS

    MDR report key: 2500971 · Received February 7, 2012

    Report

    Report Number
    MW5024709
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    January 6, 2012
    Report Date
    February 7, 2012
    Manufacturer
    ADDITION TECHNOLOGY
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INTACS CAUSED CORNEAL EDEMA THROUGH THE ANTERIOR CHAMBER IN A PT THAT HAD SEVERE KERATOCONUS IN THE CORNEA; SO, INTACS WERE REMOVED. DATES OF USE: (B)(6) 2011 - (B)(6) 2012. EVENT DID NOT REAPPEAR AFTER REINTRODUCTION: NO.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 3/20/2012: ADDITION TECHNOLOGY'S SURGEON TRAINING COURSES TEACH OF POSSIBLE COMPLICATIONS THAT MAY OCCUR PRE-INTRA AND POST OPERATIVELY. CORNEAL EDIMA IS COVERED AND IS NOT A RESULT OF THE INTACS PRODUCT BUT OF THE ALREADY EXISTING IRREGULAR CORNEA THAT IS PRESENT WITH A SEVERE KERATOCONUS CORNEA. STATEMENT FROM SURGEON: ON (B)(6) 2012, PT HAS NOT BEEN ABLE TO BE FITTED FOR HARD CONTACTS DUE TO HIS PROGRESSING KERATOCONUS. THE OPTIONS WERE INTACS OR CORNEAL TRANSPLANT FOR THE RIGHT EYE. THE PT HAD INTACS SURGERY ON (B)(6) 2011 FOR KERATOCONUS. ON (B)(6) 2012 POSTOPERATIVELY, PT WAS DEVELOPING CORNEAL EDEMA IN THE RIGHT EYE, SO THE INFERIOR INTAC WAS REMOVED ON (B)(6) 2012. THE CORNEAL EDEMA CONTINUED AND ON (B)(6) 2012, THE REMAINING SUPERIOR SEGMENT WAS ALSO EXPLANTED. THE SURGEON BELIEVES THAT THIS FAILURE WAS NO CAUSE OF THE INTACS THEMSELVES BUT THE CONDITION OF THE IRREGULAR CORNEA TO BEGIN WITH. THERE MAY BE NO ALTERNATIVE BUT TO OFFER THE PT A CORNEAL TRANSPLANT. PT IS CURRENTLY BEING CLOSELY MONITORED BY HIS OPTOMETRIST AND THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACS CORNEAL IMPLANTS CORNEAL IMPLANTS LQE ADDITION TECHNOLOGY ICI-450-150 B11H1066

    Patients

    Seq Age Sex Outcome Treatment
    1 Other