BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 14011404 · Received April 5, 2022

    Report

    Report Number
    2523835-2022-00136
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657522002
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED PHACOEMULSIFICATION (PHACO) TIP IN A TIP WRENCH WITHIN A CONTAINER WAS RECEIVED FOR THE REPORT OF THE TIP WAS BROKEN. THE PHACO TIP WAS VISUALLY INSPECTED AND DEEMED CONFORMING, THERE WAS NO BREAK OR CRACK IN THE TIP OBSERVED. THERE WAS SLIGHT WEAR ON THREADS, BACK OF FLANGE AND NUT CORNERS. 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 PHOTO PROVIDED WAS REVIEWED BY THE MANUFACTURING SITE. THE PHOTO IS OF A PHACO TIP IN A WRENCH WITHIN A CONTAINER, THE REPORTED PRODUCT COMPLAINT WAS NOT CONFIRMED. THE COMPLAINT EVALUATION DOES NOT CONFIRM THE PHACO BROKEN TIP. ALTHOUGH THERE WERE SIGNS OF USE THE REPORTED COMPLAINT WAS NOT OBSERVED. THE ROOT CAUSE FOR THE TIP WAS BROKEN CANNOT BE DETERMINED FROM THIS EVALUATION. NO ACTION WAS TAKEN AS THE PHACO TIP WAS MANUFACTURED TO SPECIFICATION. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 30X MAGNIFICATION DURING THE MANUFACTURING 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 FURTHER ACTIONS ARE REQUIRED THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT MANUFACTURING SITE UPDATED DUE TO RECEIPT OF THE ADDITIONAL INFORMATION. MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER MDR NUMBER 1993118 NO MORE SUPPLEMENTS TO THIS NUMBER. 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

    UPON REVIEW OF THE FOLLOW UP INFORMATION THE SUSPECT PRODUCT WAS DETERMINED TO BE A PHACOEMULSIFICATION (PHACO) TIP (PREVIOUSLY REPORTED AS IRRIGATION/ASPIRATION (I/A) TIP).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC TIP WAS BROKEN DURING USE. THE PROCEDURE WAS COMPLETED WITH ALTERNATE PACK. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790954 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 2518615H 00380657522002
    621325 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 2518615H 00380657522002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CENTURION SURGICAL PROCEDURE PAK| CUSTOM-PAK SURGICAL PROCEDURE PACK| DISPOSABLE POLYMER IRRIGATION & SILICONE I/A TIP