BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO IA TIP, 45 DEG, .3MM

    MDR report key: 5644395 · Received May 10, 2016

    Report

    Report Number
    3006695864-2016-00474
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 12, 2016
    Report Date
    August 18, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS FOR THE DEVICE WAS REVIEWED AND NO ANOMALIES OR DEVIATIONS FROM STANDARD MANUFACTURING PROCESSES FOR THIS PRODUCT WERE FOUND. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE FIELD SERVICE ENGINEER (FSE) VISITED CUSTOMER SITE AND CHECKED THE IRRIGATION/ ASPIRATION (IA) HANDPIECES MODEL OPOIA2045D. THE FSE FOUND THE IA HANDPIECES WERE CLOGGED. THEREFORE, THE FSE CLEANED THE IA HANDPIECES, WHICH RESOLVED THE REPORTED ISSUE. FSE ALSO CHECKED THE VACUUM WHICH WAS FINE AND THE SYSTEM WAS FOUND TO MEET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ON THE INITIAL REPORT THE UDI NUMBER WAS ENTERED INCORRECTLY AS: (B)(4). THE NUMBER SHOULD HAVE BEEN ENTERED AS (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW VACUUM PERFORMANCE DURING THE IRRIGATION/ASPIRATION (IA) MODE AND REQUESTED THE TIPS BE CHECKED. AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND CONFIRMED THAT THREE (3) IA HANDPIECES WERE CLOGGED. THERE WAS NO PATIENT INJURY AND NO DELAY IN TREATMENTS REPORTED. THIS REPORT PERTAINS TO THE I/A TIP/HAND PIECE WITH LOT NO. 054210. TWO SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER TWO TIPS OF TWO DIFFERENT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298085 SOLO IA TIP, 45 DEG, .3MM PHACO ACCESSORIES HQC ABBOTT MEDICAL OPTICS OPO1A2045D 054210

    Patients

    Seq Age Sex Outcome Treatment
    1