BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2894793 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01612
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 2, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS NOTICED FLASHING ON THE OUTER EDGE OF THE LENS. SHE IS ALSO EXPERIENCING TROUBLING DISORIENTATION AND DIZZINESS WHEN IN BRIGHT LIGHT, ESPECIALLY IN A LARGE SHOPPING AREA. THE CONSUMER REPORTED SHE HAS TO HOLD A SHOPPING CART FOR STABILITY. THE CONSUMER STATED THE LOWER PORTION OF THE LENS SEEMS TO HAVE THE MOST DISTORTION AND FEELS SWOLLEN. SHE HAS NOTICED SOME IMPROVEMENT IN HER READING ABILITY AND HER VISION AT TEN FEET IS IMPROVED, BUT DISTANCE IS ABOUT THE SAME. THE CONSUMER REPORTED EXPERIENCING GLARE AND STAR BURSTS AROUND LIGHTS THAT ARE MORE PRONOUNCED THAN SHE EXPECTED. SHE NOTED THE FLASHING AND DISORIENTATION SYMPTOMS ARE REDUCED WHEN SHE IS WEARING SUNGLASSES. THE CONSUMER REPORTED HER VISUAL ACUITY FOLLOWING THE IOL IMPLANT PROCEDURE MEASURED 20/30 AND TEN DAYS LATER WAS 20/30. HER SURGEON HAS CANCELLED THE IOL IMPLANT FOR HER FELLOW EYE UNTIL SHE IS RECHECKED IN ABOUT A MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12124516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other