BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2163605 · Received June 8, 2011

    Report

    Report Number
    1119421-2011-00698
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 9, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORD REVIEW COULD NOT BE COMPLETED DUE TO NO INFORMATION RECEIVED TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THE REPORTER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE IS UNHAPPY THAT SHE HAS TO WEAR GLASSES TO WATCH TELEVISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER REPORTED SHE WAS TOLD SHE MIGHT OR MIGHT NOT HAVE TO WEAR GLASSES TO WATCH TELEVISION PRIOR TO HER PROCEDURE. THE REPORTER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other