BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2133640 · Received June 16, 2011

    Report

    Report Number
    1119421-2011-00752
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THE LENS DID NOT CAUSE THE TEAR. AN ANTERIOR VITRECTOMY WAS ALSO PERFORMED. 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 UNACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 05/18/2011, 05/19/2011, 06/02/2011, AND 06/13/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED IN F/U PHONE CALLS ON 05/18/2011 AND 05/19/2011. ADDITIONAL INFO RECEIVED IN A F/U EMAIL ON 06/14/2011. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. IN A F/U CALL WITH THE TECH, IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE CAPSULE TORE DURING THE FINAL STAGE OF ASPIRATION. THE IOL HAD NOT BEEN IMPLANTED IN THE EYE AT THIS POINT. AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE IOL WAS PLACED IN THE SULCUS. IN A F/U PHONE CALL WITH THE SURGEON, IT WAS REPORTED THAT HE THOUGHT THE LENS WAS VAULTED, SLIGHTLY TILTED AND THERE WAS ALSO SOME RETAINED CORTICAL MATTER BEHIND THE LENS. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON'S TECH THAT THE IOL WAS EXCHANGED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON MN6AD1 11011369

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention