BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 8583874 · Received May 6, 2019

    Report

    Report Number
    9612169-2019-00087
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    December 5, 2018
    Report Date
    September 6, 2019
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS NOT OBSERVED. THE IOL WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS: ONLY ONE SEGMENT OF IOL RETURNED ADHERED TO A GAUZE INSIDE A ZIP LOCK BAG. A SIGNIFICANT AMOUNT OF SOLUTION IS DRIED ON BOTH SURFACES OF THE SEGMENT AND ONE HAPTIC. THE OPTIC IS SPLIT/CUT DIVIDING THE IOL IN SEGMENTS. OPTICAL POWER & RESOLUTION COULD NOT BE VERIFIED DUE TO THE EXTENSIVE OPTIC DAMAGE. NO ROOT CAUSE IDENTIFIED AS THE REPORTED COMPLAINT "EXPLANTED DUE TO DISLOCATED LENS" COULD NOT BE OBSERVED. THE RETURNED IOL SHOWS EVIDENCE OF POSSIBLE HANDLING BY THE CUSTOMER DUE TO THE PRESENCE OF SOLUTION AND HOW IT WAS RETURNED SPLIT/CUT DIVIDED IN SEGMENTS. THE LENS WAS CUT IN HALF THROUGH THE CENTER OF THE OPTIC. DUE TO THIS DAMAGE, A FUNCTIONAL TEST (LENS BENCH) TO CHECK THE POWER AND RESOLUTION OF THE LENS COULD NOT BE CONDUCTED. AN IMPACT TO THE VISUAL ACUITY OF THE PATIENT CANNOT BE VERIFIED BY EXAMINATION OF THE RETURNED PRODUCT. IN ADDITION TO THIS, ALL IOLS ARE 100% COSMETICALLY INSPECTED AS PER APPROVED MANUFACTURING PROCEDURES AND THE REPORTED LENS DAMAGE WOULD NOT MEET OUR CURRENT RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT ON THE FIRST POSTOPERATIVE DAY THERE WAS 1+ FLARE AND CELL IN THE ANTERIOR CHAMBER. APPROXIMATELY 3 MONTHS LATER, THERE WAS NO IMPROVEMENT IN VISION, K SCARRING, THE IOL WAS IN GOOD POSITION, 1+ POSTERIOR CAPSULE OPACITY AND TRACE EPIRETINAL MEMBRANE. APPROXIMATELY 2 YEARS LATER, THE PATIENT'S RIGHT EYE WAS RED WITH PAIN AND THE VISION HAD DECREASED TO UCVA HAND MOTION. THE IOP INCREASED TO 59. THE ANTERIOR CHAMBER HAD 4+ INFERIOR HEMORRHAGE, IRIS NEOVASCULARIZATION, THE IOL WAS IN GOOD POSITION. THE PATIENT WAS DIAGNOSED WITH SEVERE NEOVASCULAR GLAUCOMA, VITREOUS HEMORRHAGE, EPIRETINAL MEMBRANE PUCKER, AGE RELATED MACULAR DEGENERATION. THE PATIENT WAS STARTED ON MEDICATION. APPROXIMATELY 3 MONTHS LATER B-SCAN RESULTS REFLECT A VITREOUS HEMORRHAGE - IOL MAYBE RUBBING ON IRIS. THE FOLLOWING DAY THE IOL WAS OBSERVED AS DISLOCATED WITH A HYPHEMA. THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT LENS MODEL 2 WEEKS LATER.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 FACILITY REPRESENTATIVE REPORTED THAT APPROXIMATELY 2 YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION FOR 1 MONTH. THE IOL DISLOCATED, RUBBED ON IRIS CAUSING HYPHEMA AND A VITREOUS HEMORRHAGE. THERE WAS NO INDICATION OF TRAUMA. THE IOL WAS EXCHANGED FOR A DIFFERENT LENS MODEL AND ONE DIOPTER DIFFERENCE IN POWER. THE PATIENT'S VISION IS STABLE AND DOING WELL POST THE EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374968 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21150423

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention