BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IOL

    MDR report key: 18993021 · Received March 28, 2024

    Report

    Report Number
    1119421-2024-00574
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 25, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WAS OPENED FROM A STUDY REPORT: READING PERFORMANCE WITH A NON-DIFFRACTIVE ENHANCED DEPTH OF FIELD (EDOF) IOL: A RANDOMIZED CONTROLLED TRIAL. THE LAST SENTENCE OF THE REPORT STATED "ONE ADVERSE EVENT WAS RECORDED: CAPSULE RUPTURE DURING SURGERY." NO OTHER INFORMATION WAS PROVIDED WHETHER THIS WAS BEFORE OR AFTER THE LENS IMPLANT. NO INFORMATION AS TO WHICH OF THE LENS MODELS MAY HAVE BEEN INVOLVED. THERE WAS NO INDICATION IN THE REPORT THAT THE ISSUE WAS DUE TO A MALFUNCTION OF THE IMPLANTED LENS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE STUDY WAS CONDUCTED TO ASSESS THE VISUAL FUNCTION AND READING PERFORMANCE WITH ACRYSOF IQ VIVITY (TORIC AND NON-TORIC) IOL VS. STANDARD MONOFOCAL ACRYSOF IQ (TORIC AND NON-TORIC) IOL IN A RANDOMIZED COMPARATIVE STUDY. RANDOMIZED, PROSPECTIVE, SINGLE-CENTER, CONTROLLED TRIAL. RANDOMIZATION WILL BE PERFORMED USING AN ONLINE RANDOMIZATION SYSTEM THAT INDICATE WHICH PATIENT RECEIVES WHICH IOL. SIXTY-EIGHT PATIENTS WERE INCLUDED. FOURTEEN PATIENTS WERE EXCLUDED DUE TO LOSS TO FOLLOW-UP, WITHDRAWN CONSENT, SURGERY COMPLICATION AND DEVICE MALFUNCTION. THE STUDY WAS CONCLUDED WITH VERY GOOD VISUAL ACUITY FOR DISTANCE (4M), INTERMEDIATE (AT 66CM SUPERIOR TO ASPHERIC MONOFOCAL) AND EVEN NEAR VISION (AT 40CM SUPERIOR TO ASPHERIC MONOFOCAL) FOR VIVITY GROUP. HIGH PATIENT SATISFACTION AMONG THE VIVITY GROUP (QOV AND ASTON HALOMETER SIMILAR TO ASPHERIC MONOFOCAL GROUP). FIXATION DURATION SIGNIFICANTLY SHORTER IN VIVITY GROUP AT 66CM, BUT JUST MODERATELY BETTER IN READING SPEED OR NUMBER OF FIXATION. THIS FILE BELONGS TO A PATIENT WHO HAD CAPSULE RUPTURE DURING THE SURGERY. STUDY CITATION: OLIVER FINDL ET AL., READING PERFORMANCE WITH A NON-DIFFRACTIVE ENHANCED DEPTH OF FIELD (EDOF) IOL: A RANDOMIZED CONTROLLED TRIAL., VIENNA INSTITUTE FOR RESEARCH IN OCULAR SURGERY; HANUSCH-KRANKENHAUS DEPARTMENT OF OPTHAMOLOGY, VIEENA, AUSTRIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715443 ACRYSOF IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other