BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1674644 · Received May 3, 2010

    Report

    Report Number
    1119421-2010-00501
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS MAILED TO FDA ON 06/04/2010. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTS THAT THE EVENT WAS DUE TO A CALCULATION ERROR.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 04/08/2010, 04/12/2010, 04/13/2010, AND 04/16/2010 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. MEDICAL RECORDS WERE RECEIVED ON 04/08/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A PREVIOUS LASIK PROCEDURE AND REGULAR ASTIGMATISM (PRE-EXISTING). THE RECORDS INDICATED THE PATIENT DESCRIBED PERSISTENT FUZZY VISION POSTOPERATIVELY. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. THERE ARE THIRTY NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOURTEEN OF THIRTY NINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49967 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. AN6AT3 10873201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other ASPIRIN| BSS WITH EPINEPHRINE AND VANCOMYCIN| PROVISC| SIMVASTATIN| VISCOAT| VOITAREN