BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2833701 · Received November 12, 2012

    Report

    Report Number
    1119421-2012-01381
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    August 3, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ALCON RESEARCH. LTD. /HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH UNEXPECTED ASTIGMATISM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO INDICATED THE UNEXPECTED ASTIGMATIM PERSISTS AND IS NOT EXPECTED TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. /HUNTINGTON SN6AT6 12084669

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other DATE UNKNOWN| ZYMAXID| MONARCH B CATRIDGE| MONARCH III HANDPIECE| PREDNISOLONE| BROMDAY| DUOVISC