BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 6911742 · Received October 3, 2017

    Report

    Report Number
    2648035-2017-01787
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    July 24, 2017
    Report Date
    April 2, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474528840
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 02/23/2018. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED RESIDUE OF LUBRICANT MATERIAL AND LOOSE FIBERS/PARTICLES ON THE LENS RELATED TO THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. THE LENS WAS OBSERVED BENT NEAR THE LENS LOOP DRILL HOLE. ONE OF THE HAPTICS WAS OBSERVED SLIGHTLY DISTORTED. NO DAMAGE WAS OBSERVED TO THE OTHER HAPTIC. NO SCRATCHES WERE OBSERVED ON THE LENS. THE CONDITION OF THE PRODUCT RETURNED WAS CONSISTENT WITH A UNIT THAT WAS PREVIOUSLY HANDLED AND PREPARED FOR SURGICAL PROCESS. THE CUSTOMER'S REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL INVESTIGATION REQUESTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO EXAMINE THE LENS THOROUGHLY TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT, AND EXAMINE THE LENS OPTICAL SURFACES FOR OTHER DEFECTS. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO PATIENT CONTACT REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED UPON REMOVING IT FROM THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692425 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003 05050474528840

    Patients

    Seq Age Sex Outcome Treatment
    1