BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 12186111 · Received July 17, 2021

    Report

    Report Number
    1119421-2021-01396
    Event Type
    Injury
    Date Received
    July 17, 2021
    Report Date
    July 17, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT, PCO (FIBRIN) LIKE MATERIAL WAS ADHERED IN ANTERIOR CAPSULE FROM OUTSIDE OF CCC TO THE EDGE OF CCC AND IOL. LASER DID REMOVE THE MATERIAL BUT IT STILL FELT ANXIETY. ANYTHING LIKE THAT WAS NEVER OCCURRED. THE SAMPLE IS NOT AVAILABLE AS IT STILL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083178 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON AU00T0 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention