BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2000354 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00125
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 19, 2011
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED AND THE REPORTED COMPLAINT WAS OBSERVED. SOLUTION IS DRIED ON THE LENS. PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED BY THE EVALUATION. THE REPORTED OPTIC DAMAGE WAS OBSERVED AS WELL AS HAPTIC DAMAGE. DUE TO THE PRESENCE OF SURGICAL SOLUTION , THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, IT WAS NOTED THAT THE IOL WAS CRACKED. THE IOL WAS LEFT IMPLANTED. AT A LATER DATE, THE SURGEON REPORTED THE PATIENT WAS EXPERIENCING BLURRY VISION, SO THE LENS WAS EXCHANGED FOR THE SAME MODEL AND POWER IOL. THE SURGEON REPORTED THE PATIENT WAS SATISFIED WITH HIS VISION FOLLOWING THE EXCHANGE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11008045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention