BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3950865 · Received June 13, 2014

    Report

    Report Number
    1119421-2014-00440
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED GLISTENINGS WERE OBSERVED IN BOTH EYES DURING A POSTOPERATIVE EXAMINATION SEVERAL MONTHS AFTER BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. THE REASON FOR THE EXAMINATION WERE INCREASING GLARE EFFECTS. ADD'L INFO WAS REC'D FROM THE HEALTHCARE PROFESSIONAL WHO PROVIDED PRODUCT DETAILS. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS ASSOCIATED BEING FILLED FOR THIS EVENT. THIS FILE IS FOR THE RIGHT EYE (OD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350767 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 11035895

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK