BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 7021779 · Received November 10, 2017

    Report

    Report Number
    2648035-2017-02035
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 12, 2017
    Report Date
    February 21, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474530645
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DURING FOLLOW UP, THE CUSTOMER STATED THERE WAS NO PATIENT CONTACT. IT WAS CONFIRMED THAT THE ISSUE WAS LENS SHEARED. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS SHEARED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801165 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002 05050474530645

    Patients

    Seq Age Sex Outcome Treatment
    1