BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1828548 · Received September 3, 2010

    Report

    Report Number
    1119421-2010-00965
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ALCON RESEARCH, LTD/ HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE SURGEON REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC. ADD'L INFO WAS REQUESTED ON 08/06/2010 AND 08/09/2010 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/16/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "STARBURSTS, LARGE SMOKE CLOUDS, A LINE THROUGH WORDS WHEN READING" (VISUAL DISTURBANCES). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]); "UNAPPROVED VISCOELASTIC" (USE OF DEVICE ISSUE). A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE WAS SEEING STARBURSTS WHEN SUNLIGHT HITS CERTAIN OBJECTS, A LINE THROUGH WORDS WHEN READING SMALL PRINT AND THE WORDS DROP DOWN THE PAGE. THE CONSUMER REPORTED HER PRE-EXISTING VITREAL FLOATERS WERE MUCH LARGER AND APPEARED AS SMOKE CLOUDS WHICH COME DOWN THE CENTER OF HER VISION AND DANCE AROUND. THE CONSUMER REPORTED HER SURGEON ADVISED HER TO USE ARTIFICIAL TEARS AND POLARIZED SUNGLASSES, WHICH HAS NOT IMPROVED HER ISSUES. IN A F/U PHONE CALL WITH THE SURGEON, HE REPORTED THAT THE CONSUMER REPORTED EXPERIENCING A "CLOUD WITH RINGS WHEN LOOKING AT THE FENDER OF A CAR" ONCE SHE HAD STOPPED HER ROUTINE POSTOPERATIVE MEDICATIONS. THERE WAS NO REPORT OF PROBLEMS DURING CLOUDY DAYS OR UNDER FLUORESCENT LIGHTS. THE SURGEON REPORTS HIS EXAMINATION REVEALED POSTERIOR CAPSULE OPACIFICATION, ASTIGMATISM AND DRY EYES. HE INSERTED PUNCTAL PLUGS TO HELP WITH HER DRY EYES AND INSTRUCTED HER TO USE THICKER ARTIFICIAL TEARS. THE PATIENT HAS A HISTORY OF DRY EYES, DIABETES, HYPERTENSION AND VITREAL FLOATERS (PRE-EXISTING). IN A F/U, THE SURGEON REPORTED THE EVENT CONTINUES. HE HAS STARTED THE PATIENT ON MEDICATION TO TREAT POSSIBLE SUB-CLINICAL CYSTOID MACULAR EDEMA. THE SURGEON REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/ HUNTINGTON SN6AD1 11013636

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention MONARCH CARTRIDGE C| HANDPIECE II| VISCOAT/ HEALON GV