BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 6306070 · Received February 6, 2017

    Report

    Report Number
    2648035-2017-00216
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Report Date
    May 24, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474529069
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE RETURNED TO MANUFACTURER: IT HAD PREVIOUSLY BEEN REPORTED THAT THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THIS PRODUCT WAS IN FACT RETURNED TO AMO. HOWEVER, IT WAS RETURNED MARKED AS ''OPENED, NOT USED - NON-COMPLAINT''. THEREFORE, THE PRODUCT WAS PROCESSED AS A NON-COMPLAINT AND SCRAPPED ACCORDINGLY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED MISSING/DETACHED HAPTICS ON AN INTRAOCULAR LENS (IOL). NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87019 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003 05050474529069

    Patients

    Seq Age Sex Outcome Treatment
    1