BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 13967350 · Received March 31, 2022

    Report

    Report Number
    1119421-2022-00651
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 18, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. THE SUBMITTED PHOTOS WERE REVIEWED BY GLOBAL QUALITY CUSTOMER AFFAIRS. TWO PHOTOS WERE CONICAL BEAM SLIT LAMP PHOTOS FOCUSED IN THE CENTER OF THE IOL. THE FIRST SLIT LAMP PHOTO IS OF GOOD CLARITY AND IS SIGNIFICANT FOR DIFFUSE REFRACTIVE PARTICLES THAT APPEAR TO BE LOCATED WITHIN THE BODY OF THE IOL. THESE PARTICLES ARE TYPICALLY REFERRED TO AS MICROVACUOLES. IT IS DIFFICULT TO DETERMINE THE DEPTH OF THESE PARTICLES FROM THE PHOTO, AND ETIOLOGY CANNOT BE STATED WITH CERTAINTY. THE SECOND SLIT LAMP PHOTO IS QUITE BLURRY AND NO OBSERVATIONS CAN BE MADE WITH CONFIDENCE. THE THIRD PHOTO IS A FUNDUS PHOTOGRAPH OF POOR TO MODERATE QUALITY. NO SIGNIFICANT RETINAL FINDINGS CAN BE DESCRIBED WITH CERTAINTY FROM THE FUNDUS PHOTO.PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE CUSTOMER FELT LENS WAS CLOUDY, SOMETHING LIKE SSNG/ GLISTENING WAS OBSERVED. THE CUSTOMER BELIEF IT COULD BE A SCATTERING PHENOMENON OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THREE PHOTOS WERE SUBMITTED AND REVIEWED. TWO PHOTOS WERE CONICAL BEAM SLIT LAMP PHOTOS FOCUSED IN THE CENTER OF THE IOL. THE FIRST SLIT LAMP PHOTO IS OF GOOD CLARITY AND IS SIGNIFICANT FOR DIFFUSE REFRACTIVE PARTICLES THAT APPEAR TO BE LOCATED WITHIN THE BODY OF THE IOL. THESE PARTICLES ARE TYPICALLY REFERRED TO AS MICROVACUOLES. IT IS DIFFICULT TO DETERMINE THE DEPTH OF THESE PARTICLES FROM THE PHOTO, AND ETIOLOGY CANNOT BE STATED WITH CERTAINTY. THE SECOND SLIT LAMP PHOTO IS QUITE BLURRY AND NO OBSERVATIONS CAN BE MADE WITH CONFIDENCE. THE THIRD PHOTO IS A FUNDUS PHOTOGRAPH OF POOR TO MODERATE QUALITY. NO SIGNIFICANT RETINAL FINDINGS CAN BE DESCRIBED WITH CERTAINTY FROM THE FUNDUS PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042359 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 12622985

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| MONARCH III IOL DELIVERY SYSTEM, INJECTOR| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE