BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 6010137 · Received October 7, 2016

    Report

    Report Number
    2648035-2016-01566
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 13, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474529076
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 10/10/2016. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE LENS WAS RETURNED WITHOUT THE HAPTICS, THEY WERE COMPLETELY DETACHED. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION WAS PERFORMED. THE LENS WAS TORN AND WAS MOST LIKELY RELATED TO THE EXPLANT PROCESS. THE CUSTOMER'S REPORTED ISSUE COULD NOT BE VERIFIED. THE CONDITIONS OBSERVED ON THE RETURNED LENS COULD BE RELATED TO THE HANDLING OF THE LENS AND EXPLANT PROCESS. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THE MANUFACTURING PROCESS WAS EVALUATED AND THE DEVICES WERE MANUFACTURED WITHIN SPECIFICATIONS. NO NON-CONFORMANCE REPORTS (NCRS)/DEVIATIONS/DISCREPANCIES WERE ISSUED DURING THE MANUFACTURING PROCESS FOR THIS PRODUCTION ORDER. BASED ON THE MANUFACTURING DEVICE HISTORY RECORD, THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT THIS IS THE ONLY INVESTIGATION THAT HAS BEEN GENERATED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE RESULTS OF THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED WAS DUE TO LENS DISLOCATION. THERE WAS A VITRECTOMY BUT NO INCISION ENLARGEMENT AND NO PATIENT INJURY REPORTED POST-OP. SURGERY WENT WELL. FURTHER FOLLOW UP WAS PROVIDED AND THE DOCTOR CONFIRMED THERE WAS NO PRODUCT DEFECT OR QUALITY ISSUE. THE LENS WAS EXCHANGED BECAUSE IT MOVED FROM ITS' LOCATION. NO PATIENT VISION ISSUES WERE REPORTED. THE PATIENT OPTED FOR A LENS EXCHANGE. SURGERY WENT WELL AFTERWARDS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663046 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003 05050474529076

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention