BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 8965726 · Received September 5, 2019

    Report

    Report Number
    1119421-2019-01432
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    October 23, 2019
    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
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. EVALUATION OF PROVIDED PHOTOS: REVIEW PROVIDED BY GLOBAL DEVICE MEDICAL SAFETY (GDM) ((B)(4)): MULTIPLE SPOTS OF OPACIFICATION (PRESUMABLY GLISTENINGS) ARE OBSERVED ON THE IOL OPTIC. THERE IS A MASSIVE FIBRIN REACTION AND/OR CORTICAL REMNANT VISIBLE AS WELL BUT NOT EASY TO DETERMINE DUE TO A STATIC PICTURE MODE. HOWEVER, IT IS DIFFICULT TO CONCLUDE WHAT TYPE OF IOL WAS IMPLANTED. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT. GDMS EVALUATED THE PROVIDED PHOTOS. BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER, OPACIFICATION WAS OBSERVED. HOWEVER, WE CANNOT DETERMINE WHICH IOL WAS IMPLANTED THROUGH THE PHOTOS ATTACHED. A DEFINITIVE DETERMINATION OF DAMAGE CANNOT BE MADE WITHOUT THE EVALUATION OF THE PHYSICAL PRODUCT. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS PRESENTED WITH AN OPACIFICATION OR GLISTENING. THEE IS NO IMPROVEMENT IN VISION FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761548 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 21002562

    Patients

    Seq Age Sex Outcome Treatment
    1