BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2061009 · Received April 5, 2011

    Report

    Report Number
    1119421-2011-00384
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 6, 2011
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ACTION TAKEN: FURTHER ACTION IS NOT 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. ADD'L INFO WAS REQUESTED ON (B)(4) 2011 AND (B)(4) 2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/05/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING 52 CASES WHOSE POSTOPERATIVE RESULTS WERE MORE HYPEROPIC OR MYOPIC THAN EXPECTED FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. THE SURGEON REPORTED VARYING DEGREES OF HYPEROPIA/MYOPIA. SHE ALSO STATED THAT AFTER ANALYZING THE UNEXPECTED OUTCOMES, SHE STILL WOULD HAVE CHOSEN THE POWER OF IOLS SHE ORIGINALLY IMPLANTED FOR THESE PATIENTS. THE SURGEON ALSO REPORTED HAVING UNEXPECTED OUTCOMES, APPROX "0.3 OFF" TARGET, WITH TWO OTHER LENS MODELS. (NUMBER OF CASES WAS NOT PROVIDED.) THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND LENS MODEL AND FOR WHICH THE OUTCOME WAS APPROX 0.3 OFF TARGET. ADD'L 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 NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other