BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3010263 · Received March 12, 2013

    Report

    Report Number
    1119421-2013-00261
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 11, 2013
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - 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. ADD'L INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH BILATERAL UNEXPECTED REFRACTIVE OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT HAD HISTORY OF LASIK WITH SUBSEQUENT ENHANCEMENT IN BOT EYES. ADD'L INFO RECEIVED FROM THE SURGICAL COORDINATOR INDICATED THE PT HAD THE IOLS EXCHANGED IN BOTH EYES, WHICH RESOLVED THE EVENT. IN THE OPINION OF THE SURGEON, IT IS UNK WHETHER THE IOL CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104328 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AT7 12080886

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention MONARCH HANDPIECE| DUOVISC| MONARACH CARTRIDGE