BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1587854 · Received January 15, 2010

    Report

    Report Number
    1119421-2010-00038
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    November 11, 2009
    Report Date
    December 17, 2009
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 12/22/2009 AND 12/30/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/30/2009. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THREE PATIENTS (FOUR EYES) EXPERIENCING MYOPIC SURPRISES FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A FOLLOW-UP, THE SURGEON STATED THE EVENT CONTINUES. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN6AT3 10904711

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other