BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 9285092 · Received November 6, 2019

    Report

    Report Number
    1119421-2019-01865
    Event Type
    Injury
    Date Received
    November 6, 2019
    Report Date
    July 8, 2020
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A VOLUNTARY MEDICAL DEVICE REMOVAL WAS INITIATED ON (B)(6) 2020. ALL THE NON-IMPLANTED UNITS FROM THIS LOT (12726594) WERE REMOVED FROM THE MARKET. THE FDA WAS NOTIFIED OF THIS VOLUNTARY MEDICAL DEVICE REMOVAL (B)(6) 2020. TWO CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS) WERE IDENTIFIED TO ADDRESS INADEQUATE LINE CLEARANCE AND THE CONTRIBUTING FACTOR OF REJECTED UNITS LEFT IN AN OPTICAL METROLOGY FIXTURE BIN. THERE ARE NO NEW COMPLAINTS FOR THE IMPLANTED LENSES FROM THIS LOT, AND ALL NON-IMPLANTED LENSES FROM THIS LOT HAVE BEEN RECOVERED. ADDITIONAL INFORMATION WAS PROVIDED IN H.7., H.9. AND H.10. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE RETURNED LENS IS A MONOFOCAL LENS. THE LENS WAS RETURNED CUT INTO TWO PIECES INSIDE A SPECIMEN CUP. THE SPECIMEN CUP HAS BEEN LABELED WITH PATIENT AND SURGEON INFORMATION. NO PRODUCT LABELING WAS RETURNED WITH THE SAMPLE. EXACT FOCAL LENGTH/RESOLUTION MEASUREMENTS COULD NOT BE OBTAINED DUE TO THE OPTIC DAMAGE. HOWEVER, THE LENS IS NOT IN THE 20.5 DIOPTER RANGE; THE VALUE FALLS INTO THE RANGE OF A 27.5/28.0 DIOPTER. THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE AN INADEQUATE LINE CLEARANCE CONDUCTED AT COSMETICS OR LENS CASING. BASED ON THE ANALYSIS OF THE COMPLAINT SAMPLE AND PROCESS REVIEW, THE SCOPE OF THE INVESTIGATION WAS LIMITED TO INDICATED MODEL FROM 27.0 DIOPTER TO 29.0 DIOPTER AT OPTICAL METROLOGY (NIMO), LENS CASING, AND COSMETICS. NINE POTENTIAL LOTS WERE IDENTIFIED. THE ASSOCIATED PHRS WERE REVIEWED AND CONFIRMED TO HAVE ADEQUATE LOT RECONCILIATION DOCUMENTATION. THIS WOULD INDICATE THE LENS EXCHANGE MOST LIKELY OCCURRED WITH A REJECTED LENS DUE TO AN INADEQUATE LINE CLEARANCE. A SPECIFIC LOT COULD NOT BE ISOLATED AS THE LENS EXCHANGE LOT. ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.10. CORRECTED INFORMATION IN D.10. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC TECHNICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED THE PATIENT HAD A 7 DIOPTER MYOPIC REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED 9 DAYS AFTER IMPLANTATION FOR THE SAME MODEL LENS OF THE SAME POWER. THE PATIENT IS REPORTED AS DOING WELL AFTER THE LENS EXCHANGE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082170 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON AU00T0 12726594

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention