BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 20772131 · Received November 25, 2024

    Report

    Report Number
    1119421-2024-02304
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    October 28, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    ADDITIONAL INFORMATION WAS ADDED IN B.5., H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED. THE PROVIDE PHOTOS WERE REVIEWED BY GLOBAL QUALITY CUSTOMER AFFAIRS (GQCA). ADDRESSING THE REPORT OF ¿IT IS ESTIMATED THAT INTRAOCULAR LENS (IOL) OPACIFICATION OCCURRED 10 YEARS AFTER SURGERY WITH COMPANY LENS IN 2014. OPACIFICATION IS CLEAR WHEN VIEWED WITH A SLIT LAMP, AND THERE IS A DIFFERENCE FROM THE OTHER EYE IN THE PATIENT'S FUNDUS PHOTO,¿ THE PROVIDED IMAGE IS MODERATELY BLURRY, SHOWING A COMPUTER MONITOR WITH RIGHT AND LEFT EYE POSTERIOR POLE FUNDUS PHOTOGRAPHS ON THE LEFT SIDE, AND A SLIT LAMP IMAGE ON THE RIGHT. A GENERAL OBSERVATION OF THE FUNDUS PHOTOS DEMONSTRATES THAT THE RIGHT EYE APPEARS DARKER OVERALL THAN THE LEFT. HOWEVER, DUE TO THE BLURRY IMAGE, FURTHER DETAILS CANNOT BE ACCURATELY ASSESSED AND COMPARED. REGARDING THE LENS FINDINGS IN THE SLIT LAMP IMAGE, ONLY THE CENTRAL AREA OF THE LENS IS VISIBLE THROUGH THE MIOTIC PUPIL. WHILE THE VISIBLE AREA APPEARS CLOUDY, FURTHER DETAILS CANNOT BE ASSESSED DUE TO THE LIMITATIONS OF THE IMAGE QUALITY AND THE MIOTIC PUPIL. GIVEN THESE CONSTRAINTS, THE IDENTITY OF THE CLOUDY APPEARING LENS CANNOT BE DETERMINED FROM THIS PHOTO REVIEW ALONE, FURTHER EVALUATION IS NECESSARY TO ACCURATELY IDENTIFY REPORTED OPACIFICATION AND DETERMINE ITS RELEVANCE TO THE COMPLAINT INVESTIGATION. THE COMPLAINT HISTORY AND 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. ASSOCIATED PRODUCT INFORMATION WAS NOT PROVIDED. THE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED COMPLAINT. PHOTOS WERE PROVIDED. BASED ON THE REVIEW OF THE PROVIDED PHOTOS, THERE APPEARED TO BE A POTENTIALLY CLOUDY AREA OF THE LENS IN THE EYE. THE PHOTOS WERE TAKEN 10 YEARS AFTER SURGERY WITH COMPANY LENS IN 2014. DUE TO THE BLURRY IMAGE, FURTHER DETAILS CANNOT BE ACCURATELY ASSESSED AND COMPARED. IT IS DIFFICULT TO MAKE A FINAL DETERMINATION WITHOUT EVALUATION OF THE PHYSICAL SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED BASED ON AVAILABLE INFORMATION. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUEST FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS ESTIMATED THAT IOL OPACIFICATION OCCURRED 10 YEARS AFTER SURGERY. OPACIFICATION WAS CLEAR WHEN VIEWED WITH A SLIT LAMP, AND THERE WAS A DIFFERENCE FROM THE OTHER EYE IN THE PATIENT FUNDUS PHOTO. CURRENTLY, THE PATIENT UNCORRECTED VISION WAS 0.1 AND THE CORRECTED VISUAL ACUITY WAS 0.1, AND THE PATIENT COMPLAINS OF INCONVENIENCE IN DAILY LIFE. IT SEEMS THAT IOL FIXATION SHOULD BE PERFORMED INSTEAD OF SIMPLE IOL REMOVAL BY REMOVING THE IOL THAT HAS BEEN 10 YEARS OLD, AND SINCE THE HOSPITAL WAS NOT CURRENTLY PERFORMING IOL FIXATION, IT WAS SCHEDULED TO BE TRANSFERRED TO ANOTHER HOSPITAL. ADDITIONAL INFORMATION HAS BEEN RECEIVED ADDRESSING THE REPORT OF "IT WAS ESTIMATED THAT IOL OPACIFICATION OCCURRED 10 YEARS AFTER SURGERY WITH COMPANY LENS. OPACIFICATION WAS CLEAR WHEN VIEWED WITH A SLIT LAMP, AND THERE WAS A DIFFERENCE FROM THE OTHER EYE IN THE PATIENT FUNDUS PHOTO," THE PROVIDED IMAGE WAS MODERATELY BLURRY, SHOWING A COMPUTER MONITOR WITH RIGHT AND LEFT EYE POSTERIOR POLE FUNDUS PHOTOGRAPHS ON THE LEFT SIDE, AND A SLIT LAMP IMAGE ON THE RIGHT. A GENERAL OBSERVATION OF THE FUNDUS PHOTOS DEMONSTRATES THAT THE RIGHT EYE APPEARS DARKER OVERALL THAN THE LEFT. HOWEVER, DUE TO THE BLURRY IMAGE, FURTHER DETAILS CANNOT BE ACCURATELY ASSESSED AND COMPARED. REGARDING THE LENS FINDINGS IN THE SLIT LAMP IMAGE, ONLY THE CENTRAL AREA OF THE LENS WAS VISIBLE THROUGH THE MIOTIC PUPIL. WHILE THE VISIBLE AREA APPEARS CLOUDY, FURTHER DETAILS CANNOT BE ASSESSED DUE TO THE LIMITATIONS OF THE IMAGE QUALITY AND THE MIOTIC PUPIL. GIVEN THESE CONSTRAINTS, THE IDENTITY OF THE CLOUDY APPEARING LENS CANNOT BE DETERMINED FROM THIS PHOTO REVIEW ALONE, FURTHER EVALUATION WAS NECESSARY TO ACCURATELY IDENTIFY REPORTED OPACIFICATION AND DETERMINE ITS RELEVANCE TO THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 0

    IOL OPACIFICATION OCCURRED DUE TO GLISTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255715 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Other