BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2930350 · Received January 22, 2013

    Report

    Report Number
    1119421-2013-00058
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 23, 2012
    Manufacturer
    ALCON MANUFACTURING, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS EYE IS VERY PAINFUL AND THAT HIS VISION IS IMPAIRED, WITH "SUBSEQUENT PHYSICAL SYMPTOMS" REMAINING FOR FIVE MONTHS POSTOPERATIVELY. THE CONSUMER REPORTED THE SURGEON'S COMMENT WAS "THERE IS NOTHING WRONG." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30989 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD./ HUNTINGTON SN6AT5 12027685

    Patients

    Seq Age Sex Outcome Treatment
    1 Other