BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 4886311 · Received July 2, 2015

    Report

    Report Number
    9612169-2015-00544
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    September 9, 2015
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THREE PHOTOS WERE PROVIDED AND EVALUATED. THESE PHOTOS WERE DARK FIELD TECHNIQUE SLIT LAMP IMAGES OF AN EYE IMPLANTED WITH AN INTRAOCULAR LENS (IOL). MULTIPLE LIGHT SCATTERING ARTIFACTS/APPARENTLY MICROVACUOLES CAN BE OBSERVED IN PHOTOS 1 & 2, WHICH APPEAR TO BE LOCATED IN THE IOL BODY, THE ARTIFACTS/MICROVACUOLES ARE OF VARIABLE DIAMETER, WHICH CANNOT BE DETERMINED ACCURATELY BASED ON THE IMAGE; HOWEVER, SEEM TO HAVE AN APPROXIMATE DIAMETER OF =0.1MM. ADDITIONALLY, IN PHOTOS 2 & 3 A WHITENING IN ALL THE ANTERIOR CAPSULE REMNANT EDGE AND IN THE PERIPHERAL OF POSTERIOR CAPSULE AT 3:00, FROM 5:00 TO 10:00 AND AT 12:00 MAY BE OBSERVED. THE OBSERVED LIGHT SCATTERING ARTIFACTS ARE COMPATIBLE WITH GLISTENINGS. THE ANTERIOR AND POSTERIOR CAPSULE WHITENING FINDINGS, ARE COMPATIBLE WITH ANTERIOR AND POSTERIOR CAPSULE OPACIFICATION RESPECTIVELY. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. NO DETERMINATION COULD BE MADE FROM THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER. WE ARE UNABLE TO CONFIRM PRODUCT DAMAGE WITHOUT EVALUATION OF THE PHYSICAL PRODUCT. BASED ON THIS, WE ARE UNABLE TO VERIFY IF THE PRODUCT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A SURGEON REPORTED MASSIVE INCLUSIONS AND CLOUDING IN AN INTRAOCULAR LENS (IOL) AFTER A CATARACT SURGERY THAT WAS PERFORMED IN 2007. ACCORDING TO THE REPORTER, THERE ARE ALSO PERIPHERAL CLOUDINGS THAT ARE DUE TO A REGENERATIVE AFTER-CATARACT COMING FROM RIND RESIDUES. AFTER THE SLIT LAMP EXAMINATION, THE IOL APPEARS ON THE WHOLE FINE-GRAINED CLOUDED. THE FUNDUS INSIDE VIEW IS REPORTED TO BE GOOD, SO THAT THE CLOUDING IS NOT AFFECTING THE PATIENT'S VISUAL ACUITY. THE PATIENT HAD ALREADY RETINA CHANGES AND THEREFORE IS NO VISUAL ACUITY DECREASE DUE TO THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432885 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 20706439

    Patients

    Seq Age Sex Outcome Treatment
    1 Other