BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1927629 · Received December 10, 2010

    Report

    Report Number
    1119421-2010-01371
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 12, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 11/18/2010, 11/20/2010, 11/29/2010, AND 12/03/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D ON 12/09/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PT HAD A HISTORY OF AMBLYOPIA AND A POSSIBLE FORME FRUSTE KERATOCONUS. IN A F/U, THE SURGICAL CONSULTANT FOR THE SURGEON REPORTED THAT THE LENS WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AT5 10948613

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DUOVISC| MONARCH DELIVERY SYSTEM