BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR MULTIFOCAL TORIC

    MDR report key: 2230716 · Received August 17, 2011

    Report

    Report Number
    1119421-2011-00995
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A STUDY PT UNDERWENT A YAG LASER CAPSULOTOMY TO REMOVE POSTERIOR CAPSULE OPACIFICATION (PCO) AND EXPERIENCED CYSTOID MACULA EDEMA. IN A F/U, THE SURGEON REPORTED THE PT ALSO EXPERIENCED A REDUCTION OF VISUAL ACUITY AND THE PT WAS TREATED WITH MEDICATIONS. IN HIS OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT AND IT IS EXPECTED TO RESOLVE WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ RESTOR MULTIFOCAL TORIC INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/HUNTINGTON SND1T2 11062734

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUOVISC