BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2020615 · Received February 10, 2011

    Report

    Report Number
    1119421-2011-00090
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 5, 2010
    Report Date
    January 11, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED AND THE REPORTED COMPLAINT OF A CRACKED OPTIC WAS NOT OBSERVED. THE OPTIC WAS SCRATCHED, WHICH MAY HAVE BEEN INTERPRETED AS THE REPORTED COMPLAINT. PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED BY THE EVALUATION. THE REPORTED COMPLAINT WAS NOT OBSERVED. LENS DAMAGE WAS OBSERVED. DUE TO THE PRESENCE OF BLOOD AND SURGICAL SOLUTION, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED NOTING A CRACK ON THE INTRAOCULAR LENS (IOL) AFTER INSERTION. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE REPORTER STATED THAT THE TEMPERATURE OF SURGERY ROOM WAS COLD AND THE LENS MATERIAL SEEMED HARDER THAN USUAL. PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 11057842

    Patients

    Seq Age Sex Outcome Treatment
    1