BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2267762 · Received September 23, 2011

    Report

    Report Number
    1119421-2011-01174
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 25, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 08/25/2011 AND 08/29/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/01/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH RESIDUAL ASTIGMATISM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN FOLLOW-UP, THE SURGEON CONTINUES TO MONITOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 12050314

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other