BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC

    MDR report key: 13926166 · Received March 28, 2022

    Report

    Report Number
    2523835-2022-00123
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    March 15, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    ONE OPENED VISCOSURGICAL DEVICE CANNULA ON A SYRINGE IN A ZIP TOP BAG WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND WAS FOUND TO BE NONCONFORMING, THE CANNULA IS BENT. NO OTHER DEFECTS WERE OBSERVED ON THE TIP OF THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE TIP WAS FOUND TO BE CONFORMING, THEREFORE THE TIP SLICED DESCRIBED IN THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. THE RETURNED SAMPLE IS VISUALLY NON-CONFORMING WITH A BENT CANNULA; HOWEVER, SINCE THE CANNULA WAS RETURNED OPENED, HOW AND WHEN THE NEEDLE BECAME BENT COULD NOT BE DETERMINED. THE CANNULA TIP WAS MANUFACTURED TO SPECIFICATIONS AND THE EXACT ROOT CAUSE FOR THE BENT CANNULA IS UNKNOWN, THEREFORE SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL CANNULA ASSEMBLIES MANUFACTURED ON THE ACAM ARE 100% BY VISION DETECTION SYSTEM AND 100% FUNCTIONALLY TESTED FOR AIR FLOW DURING THE AUTOMATED ASSEMBLY PROCESS. 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 · 0

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

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE TIP OF AN OPHTHALMIC VISCOELASTIC PRODUCT WAS SLICED DURING A SURGERY. THE INTRA-OCULAR LENS (IOL) WAS PLACED INTO THE CAPSULAR BAG AND EVERYTHING SEEMED TO BE FINE AFTER THE SURGERY, BUT THE PATIENT EYE CAPSULE WAS RUPTURED AND WEAKENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE CAPSULE WAS INJURED DURING INITIAL VISCOELASTIC INJECTION. THE SURGERY WAS COMPLETED CAREFULLY AND TOOK LONGER THAN NORMAL. THE CAPSULORHEXIS WAS NOT COMPLETED AND THE CUSTOMER IS NOT SURE IF IT WOULD AFFECT THE PATIENT IN FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878541 ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC CANNULA, OPHTHALMIC HMX ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 13MAJ8

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other UNSPECIFIED PANOPTIX.| UNSPECIFIED PROVISC OVD.