BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1912794 · Received November 3, 2010

    Report

    Report Number
    1119421-2010-01191
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 4, 2010
    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
    IA, US
    Reporter Occupation
    OTHER

    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 INFO WAS REQUESTED ON 10/05/2010, 10/07/2010 AND 10/18/2010 BY PHONE, MAIL AND FAX. ADDITIONAL INFO WAS RECEIVED ON 10/18/2010 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED, A PT WITH RESIDUAL ASTIGMATISM FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO WAS RECEIVED FROM THE NURSE, WHO STATED, SHE REPORTED THE EVENT PREMATURELY. THERE WILL BE NO INTERVENTION AND BOTH THE SURGEON AND PT ARE VERY HAPPY WITH THE OUTCOME. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN6AT5 11004109

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other