BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2093517 · Received April 6, 2011

    Report

    Report Number
    1119421-2011-00376
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 7, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS RETURNED FOR ANALYSIS. THE REPORTED COMPLAINT, IF FOREIGN MATERIAL WAS NOT OBSERVED. A SURFACE IMPERFECTION WAS OBSERVED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE WAS DETERMINED TO BE MFG RELATED. THE SURFACE IMPERFECTION DOES NOT MEET RELEASE CRITERIA. ACTION TAKEN: THIS COMPLAINT WILL BE REVIEWED WITH INSPECTION PERSONNEL AS A PROACTIVE MEASURE FOR CONTINUOUS IMPROVEMENT. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 03/09/2011 AND 03/24/2011 BY MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED NOTICING "SOMETHING" ON THE INTRAOCULAR LENS (IOL). PT IMPACT IS UNK. ADDITIONAL INFO 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 SN6AT3 10978702

    Patients

    Seq Age Sex Outcome Treatment
    1