BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM-PAK SURGICAL PROCEDURE PACK

    MDR report key: 16478274 · Received March 3, 2023

    Report

    Report Number
    1644019-2023-00219
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    September 19, 2019
    Report Date
    March 24, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETAIN THE PRODUCT LOT INFORMATION FOR THIS PROCEDURE PACK, THEREFORE THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED PROCEDURE PACK COULD NOT BE REVIEWED. THE CUSTOMER REPORTED A CLAIM AGAINST A UNIDENTIFIED SURGICAL PRODUCT. THE DOCUMENTATION ATTACHED TO THIS FILE STATES THE ANTERIOR CHAMBER CANNULAS UTILIZED IN CATARACT SURGERIES AT THE REPORTING FACILITY WERE SUPPLIED BY BEAVER VISITEC INTERNATIONAL, INC. OR ALCON LABORATORIES, INC. DOCUMENTATION RECEIVED NOTED THAT DURING THE STROMAL HYDRATION THE ANTERIOR CANNULA CAME OFF AND FLEW OFF THE TABLE, AT THIS POINT WAS ZONULAR DEHISCENCE WITH THE LENS TIPPING BACKWARDS THROUGH THE DEHISCENCE WAS NOTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE CUSTOMER DID NOT RETAIN THE LOT NUMBER. NO PHYSICAL SAMPLE HAS BEEN RETURNED FOR EVALUATION, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. WHEN THIS TYPE OF ISSUE OCCURS, A SAMPLE WILL NEED TO BE RETURNED SO THAT A PROPER INVESTIGATION CAN BE CONDUCTED. HOWEVER, THE CUSTOMER PROVIDED A PHOTO OF POSSIBLE SUSPECT PRODUCT; ANTERIOR CHAMBER CANNULA RYCROFT REF# (B)(4), LOT 6038111. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED AND THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. WITHOUT ANALYSIS OF THE SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. AS THE ROOT CAUSE IS UNKNOWN, THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT CANNOT BE DETERMINED. THE ROOT CAUSE FOR THIS COMPLAINT IS NOT KNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. BASED ON CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED WHILE PERFORMING THE CATARACT PROCEDURE PATIENT¿S RIGHT EYE WAS INJURED DURING THE STROMAL HYDRATION THE ANTERIOR CHAMBER (AC) CANNULA CAME OFF AND FLEW OFF THE TABLE, AT THIS POINT WAS ZONULAR DEHISCENCE WITH THE LENS TIPPING BACKWARDS THROUGH THE DEHISCENCE WAS NOTED, FURTHER RESULTING IN A LARGE AND IMMEDIATE PRESSURE BOLUS INTO THE AC WHICH CAUSED A CAPSULAR RUPTURE AND INTRAOCULAR LENS GETS DISPLACED TEARING THE RETINA INTO THE VITREOUS CAVITY IN TWO PLACES WHICH REQUIRED AN ADDITIONAL EMERGENCY PROCEDURE PERFORMED ON THE NEXT DAY, PATIENT ENDED UP WITH A PERMANENT LOSS OF VISION IN HIS RIGHT EYE; THIS LEGAL REPORT CONCERNING A CLAIM AGAINST THE CANNULA.

    Description of Event or Problem · 0

    IN REVIEW OF THE PROVIDED DOCUMENTATION THE ACTUAL PRODUCT ALLEGATION COULD NOT BE DETERMINED THEREFORE THE SUSPECT WAS CONSIDERED AS UNSPECIFIED SURGICAL PRODUCT, IT WAS ALSO MENTIONED THAT PER THE OPERATIVE NOTE THE PRODUCT COULD BE AN AC [ANTERIOR CHAMBER] CANNULA, HOWEVER THE MANUFACTURER OR PRODUCT DETAILS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870623 CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| S