BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1023766 · Received March 21, 2008

    Report

    Report Number
    1119421-2008-00175
    Event Type
    Other
    Date Received
    March 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 ARE NO OTHER REPORTS IN THE LOT. ADDITIONAL INFORMATION WAS REQUESTED ON 02/20/2008 AND 02/25/2008 BY PHONE. ADDITIONAL INFORMATION WAS RECEIVED VIA FAX FROM THE REPORTER. THIS REPORT WAS MAILED TO FDA ON: 03/21/2008.

    Description of Event or Problem · 1

    A NURSE REPORTED AN INTRAOCULAR LENS (IOL) ROTATED FROM AXIS 113 TO AXIS 75 SIX WEEKS FOLLOWING IMPLANT SURGERY. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS A BCVA OF 20/20. THE SURGEON DOES NOT PLAN TO ROTATE THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60T5 10721426

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other ATIVAN| DUO VISC| PROPARACAINE| MARCAINE| XIBROM| 1% XYLOCAINE SOLUTION| TOBRADEX| PHACO SOLUTION| LIDOCAINE