BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 6186096 · Received December 19, 2016

    Report

    Report Number
    9612169-2016-00168
    Event Type
    Injury
    Date Received
    December 19, 2016
    Report Date
    March 21, 2017
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE IOL MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ZIP CODE IS NOT INDICATED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ONE SLIT LAMP IMAGE SHOWING MULTIPLE LIGHT SCATTERING ARTIFACTS/ MICROVACUOLES APPARENTLY LOCATED IN THE IOL BODY. MILD WHITENING OF THE REMNANT ANT CAPSULE IS ALSO OBSERVED. OBSERVATIONS MAY BE COMPATIBLE WITH ANT CAPSULE OPACIFICATION AND GLISTENINGS. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. NO DETERMINATION COULD BE MADE FROM THE PHOTO PROVIDED BY THE CUSTOMER. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT A PATIENT EXPERIENCED DECREASED VISUAL ACUITY IN RIGHT EYE (OD) SEVERAL YEARS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. THE PATIENT DESCRIBED THAT SYMPTOMS HAD BEEN HAPPENING FOR MONTHS/A YEAR, AT ALL TIMES REGARDLESS OF LIGHT CONDITIONS. AT EXAMINATION, DIFFUSE CHANGES WITHIN THE IOL WERE OBSERVED, DESCRIBED AS FINE AND DENSE DOTS DECREASING LENS TRANSPARENCY ACROSS THE ENTIRE LENS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838340 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 20912935

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other HEALON 1%