BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 3602084 · Received January 31, 2014

    Report

    Report Number
    2020664-2014-00007
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):ACCOUNT REPORTED THAT TUBING PACK WAS DISCARDED.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    VISUAL ACUITY WAS 10/10. PINHOLE 2 WITH CORRECTION. THE IOL PLACED IN THE SULCUS WAS DECENTERED. NO KNOWN CONSEQUENCES TO PATIENT SURGEON REPORTED THAT HE DOES NOT EXPECT ISSUES WITH NIGHT VISION EITHER. A REVIEW OF MANUFACTURING RECORD REVIEW OF THE PRODUCT SHOWS THAT ALL TUBING SETS WERE RELEASED WITHIN SPECIFICATION WHEN THE LOT WAS COMPLETED. METHODS AND RESULTS UPDATED BASED ON THE NEW INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 2648035. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURING DATE. EXPIRATION DATE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCLUSION CODE WAS ADDED FOR THE MANUFACTURING RECORD REVIEW. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE IS SEPTEMBER 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SURGEON EXPERIENCED AN ISSUE WITH A OPO71 LOT CM01723 DURING A SURGERY.THE TUBING PACK HAD AN IRRIGATION ISSUE. IRRIGATION DID NOT STOP. CUSTOMER BELIEVES THE PROBLEM MIGHT BE DUE TO THE OPO71. PATIENT EXPERIENCED A BROKEN CAPSULE THAT REQUIRED A VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67968 SIGNATURE PACK, DISPOSABLE TUBING PHACO TUBING HQC ABBOTT MEDICAL OPTICS OPO71

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention