BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINAR FLOW PHACO TIP 30D 21G INFSL

    MDR report key: 7278866 · Received February 16, 2018

    Report

    Report Number
    3006695864-2018-00326
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 23, 2018
    Report Date
    October 22, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    UDI-DI
    05050474537200
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS 1 OF 5 SUPPLEMENTAL REPORTS: DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 04/11/2018. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: FIVE OPOCR3021L PHACO TIPS WERE RECEIVED WITHIN THEIR ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER OF 3821898. FOUR OF THE SAMPLES WERE STILL SEALED INSIDE BOTH THE INNER AND OUTER STERILE POUCHES. THE FIFTH SAMPLE WAS RETURNED OPENED. A VISUAL INSPECTION OF THE OPENED PHACO TIP REVEALED AN TRANSLUCENT SILICONE-LIKE PARTICLE LODGED IN THE TIP. THIS REPORT IS FOR THE TIP THAT WAS VERIFIED AS CLOGGED. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR PART NO. OPOCR3021L, LOT # 3821898 SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE BATCH RECORD REVIEW WAS CONDUCTED WITH NO DEFECTS AND NO ADDITIONAL INFORMATION BEING FOUND RELATING TO THIS ISSUE. THE FOREIGN MATERIAL IN THE NEEDLE APPEARS TO BE FROM THE SILICONE TUBING THAT THE PHACOEMULSIFICATION NEEDLE IS MANUALLY PRESSED INTO. THIS MANUAL OPERATION FIRST OCCURS AT MANUFACTURER. AFTER PRODUCT IS SHIPPED, IT IS UNKNOWN WHAT PROCESS STEPS ARE OCCURRING IN THE FIELD. IT IS UNKNOWN WHETHER OR NOT THESE NEEDLES ARE REMOVED FROM THE SILICONE TUBING AND THEN REINSTALLED BY FIELD PERSONNEL PRIOR TO SURGICAL USE DURING SETUP OR TESTING ACTIVITIES. IF THE NEEDLES ARE REINSTALLED INTO THE SILICONE TUBING AFTER THE MANUFACTURER PROCESS DURING FIELD ACTIVITIES, IT IS POSSIBLE THAT THIS FOREIGN MATERIAL COULD BE INTRODUCED INTO THE NEEDLE AT THIS TIME AS WELL. AS A PROACTIVE CORRECTIVE ACTION - MANUFACTURING CURRENTLY PERFORMS 100% INSPECTION UNDER MAGNIFICATION AFTER THE NEEDLE IS MANUALLY PRESSED INTO THE SILICONE TUBING. INSPECTION FOR THIS CONDITION HAS BEEN UPDATED TO INCLUDE MORE DETAIL WITHIN THE PROCESS WORK INSTRUCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE, THE LAMINAR FLOW PHACO TIP WAS CLOGGED. THE OPERATING ROOM COULD NOT USE FIVE (5) OF THEIR PHACO TIPS AS THEY WERE CLOGGED AND DID NOT ALLOW IRRIGATION. WHEN THE CLOGGED TIP ISSUE WAS NOTED, THE CENTER CHANGED THE TIP WITHOUT CONSEQUENCE ON THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED. THIS REPORT IS ONE (1) OF FIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119714 LAMINAR FLOW PHACO TIP 30D 21G INFSL PHACO ACCESSORY HQC ABBOTT MEDICAL OPTICS OPOCR3021L 3821898 05050474537200

    Patients

    Seq Age Sex Outcome Treatment
    1