BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC

    MDR report key: 12496928 · Received September 20, 2021

    Report

    Report Number
    2523835-2021-00351
    Event Type
    Injury
    Date Received
    September 20, 2021
    Date of Event
    July 21, 2021
    Report Date
    December 16, 2021
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF CANNULA CAME SHOOTING OFF AND CREATED ZONUALR DIALYSIS; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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 · 1

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED THAT LENS COME SHOOTING OFF AT END OF CASE. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 1 WEEK AFTER INITIAL IMPLANTATION. THE LENS WAS EXPLANTED DUE TO CANNULA CREATING ZONULAR DIALYSIS. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE INTRAOCULAR (IOL) LENS EXCHANGED WAS NOT DUE TO LENS MALFUNCTION. THE CANNULA SHOT OFF AT THE END OF THE CASE AND CREATED ZONULAR DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395904 ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC CANNULA, OPHTHALMIC HMX ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ACRYSOF IQ PANOPTIX| ACRYSOF IQ PANOPTIX