BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 5926215 · Received September 2, 2016

    Report

    Report Number
    1119421-2016-01255
    Event Type
    Injury
    Date Received
    September 2, 2016
    Report Date
    September 23, 2016
    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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. PHOTO ASSESSMENT PROVIDED BY A COMPANY PHYSICIAN: DARK FIELD PHOTO SHOWING VISUAL ARTIFACT IN INFERIOR HALF, THAT MAY BE COMPATIBLE WITH LIGHT REFLEX, AND PERIPHERAL OPACIFICATION TOWARDS CENTER, WITH PARTIAL VIEWS OF RED REFLEX FROM FUNDUS. UNABLE TO DETERMINE ORIGIN OF OPACITY NOR OF VISUAL ARTIFACT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. IT IS DIFFICULT TO MAKE A FINAL DETERMINATION WITHOUT EVALUATION OF THE PHYSICAL SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED BASED ON AVAILABLE INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO MALFUNCTION CAN BE DETERMINED AT THIS TIME. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS HAS BECOME COMPLETELY CALCIFIED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE LENS HAS BEEN REMOVED IN A SECOND PROCEDURE. THE SURGEON REPORTED THAT THERE WAS SIGNIFICANT FIBROSIS BETWEEN THE TWO LENSES THAT GAVE CHANGE FOR THE CALCIFICATION. THE LENSES SHOWED NO VISIBLE ANOMALIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577403 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON MA60BM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN IOL