BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 7579277 · Received June 7, 2018

    Report

    Report Number
    1119421-2018-00725
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 19, 2020
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE INITIAL REPORTER CONTACTED US IN A FURTHER STATEMENT AND ADDED INFORMATION REGARDING THE ERROR MODE OF THE IOLS IN QUESTION THAT THE UV FILTER HAD BECOME DARK DUE TO AGE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER INDICATED THE USE OF A QUALIFIED COMPANY II (B) CARTRIDGE AND COMPANY II HANDPIECE. COMPANY PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION.ROOT CAUSE: THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY IN BOTH EYES, BOTH IOL'S HAVE GLISTENINGS. THIS RECORD IS FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NEW INFORMATION RECEIVED FROM THE CONSUMER STATING THE CHANGE IN THE VISUAL ACUITY WAS NOTICED YEARS AFTER THE SURGERY. SHE ADDED THAT NOW IT HAS DETERIORATED RAPIDLY. SHE HAS PROBLEMS WITH READING FOR LONG PERIODS AND SHE CAN NOT SEE CLEARLY. SHE ADDED THAT HER PHYSICIAN THINKS THAT IT IS DUE TO THE AGING OF THE LENS. THE VISION IS NOT LIKE THE FIRST FEW YEARS AFTER THE SURGERY. THE PATIENT ADDED THAT BEFORE THE IOL IMPLANTATION, SHE COULD NOT SEE. AFTER THE IOL IMPLANTATION, SHE CAN SEE WELL. NOW HER VISION HAS BECOME BAD, HOWEVER NOT WORSE THAN BEFORE THE IOL IMPLANTATION. THIS IS ONE OF TWO ASSOCIATED REPORTS FILED FOR THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE OF THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422874 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON SN60WF 10741989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEALON| MONARCH B CARTRIDGE| MONARCH II HANDPIECE