BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3940271 · Received June 19, 2014

    Report

    Report Number
    9612169-2014-00070
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON THE RESULT FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL INF HAS BEEN REQUESTED BUT NOT YET RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED BLINKING IN HER RIGHT EYE AFTER UNEVENTFUL INTRAOCULAR LENS (IOL) IMPLANTATION. THE CONSUMER REPORTED THESE DISTURBANCES WERE VERY IRRITATING FOR HER AND SHE WAS HAVING DIFFICULTIES AT WORK DUE TO THIS. THE BLINKING HAPPENED WITH EVERY MOMENT OF THE EYE, ESPECIALLY WHEN LOOKING AT DISTANCES CLOSER THAN 40-60 CM (SEVERAL TIMES A SECOND). THE CONSUMER DESCRIBED THE BLINKING AS A RING SHAPED TREMBLING PHENOMENON WITH SIZE ABOUT HALF OF THE EYE, AFFECTING SHARPNESS AND MAKING IT DIFFICULT TO PERFORM TASK REQUIRING SHARP VISION OR CLOSE DISTANCE VISION. THE SYMPTOMS WERE WORSE IN THE EVENING THAN IN THE MORNINGS AND ALSO VARIED DEPENDING ON THE LIGHTING. THE FREQUENCY DID NOT CHANGE. THE CONSUMER ALSO REPORTED READING WAS STRESSFUL AND IRRITATING AND CAUSED HEADACHE AND SOMETIMES NAUSEA AND SHE WAS ABLE TO READ FOR PERIODS LONGER THAN HALF AN HOUR. THE CONSUMER INDICATED THE BLINKING STARTED ONE OR A FEW DAYS AFTER SURGERY AND WAS PERSISTING 10 WEEKS AFTER SURGERY, AT THE TIME OF REPORTING. THE CONSUMER HAD NOT EXPERIENCED BLINKING ISSUES PRIOR TO SURGERY. THE CUSTOMER COMMUNICATED WITH THE SURGEON AFTER SURGERY AND WAS ALSO VISITED BY ANOTHER OPHTHALMOLOGIST POSTOPERATIVELY. SHE WAS ADVISED TO TRY PARASYMPATHOMIMETIC DROPS (ONE DROP WASHED OFF WITH ARTIFICIAL TEARS), WHICH DID NOT HELP AND ANTIHISTAMINE PILLS WHICH HELPED. AFTER VISITING A THIRD DOCTOR SHE WAS PRESCRIBED ANTICHOLINERGIC DROPS WHICH HELPED FOR A SHORT PERIOD OF TIME. ACCORDING TO THE CONSUMER FOUR WEEKS AFTER SURGERY THE SYMPTOMS WORSENED AND READING FROM A SCREEN INFLUENCED BLINKING. THE CONSUMER ALSO MENTIONED "SHE DID NOT FEEL SICK ANYMORE AND WATCHING THINGS IN STORES DID NOT BOTHER AS MUCH AS DURING THE FIRST WEEKS". DURING THE LAST WEEK, WHEN WATCHING TV THE EYE FELT LIKE TREMBLING FROM TIME TO TIME. SHE ALSO REPORTED SOME SMALL MOVEMENTS FELT UNCOMFORTABLE (ONE EYE FELT DIFFERENT THAN THE OTHER). THE CONSUMER PROVIDED HEALTHCARE PROFESSIONAL DETAILS. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360892 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21088747

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention