BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4941809 · Received July 27, 2015

    Report

    Report Number
    9612169-2015-00562
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    June 22, 2015
    Report Date
    October 2, 2015
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS IN TRANSIT TO THE MANUFACTURING SITE FOR INVESTIGATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED TO THE LENS WHICH MOST LIKELY OCCURRED DURING THE EXPLANTATION PROCESS. RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE LENS WAS RETURNED IN A SPECIMEN CONTAINER IN A CLEAR UNKNOWN LIQUID. THE OPTIC WAS TORN/SPLIT/CRACKED (CUT) AND HAD SCRATCHES/MARKS-REJECTABLE. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE PATIENT EXPERIENCED AN OCULAR HYPERTONIA DUE TO THE REGULAR FRICTIONS OF THE IMPLANT AGAINST THE POSTERIOR FACE OF THE IRIS, A PIGMENT DISPERSION IN THE IRIDOCORNEAL ANGLE AND AN ENDOTHELIAL CELLS DENSITY DECREASE. THE PATIENT ALSO EXPERIENCED A DECREASE OF VISION AND AN INTENSE PAIN. THE IOL HAD TO BE EXPLANTED AND A NEW IOL WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485728 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21039395

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R