BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 7637308 · Received June 26, 2018

    Report

    Report Number
    2648035-2018-00906
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    May 17, 2018
    Report Date
    August 16, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474528895
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 07/17/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE LENS WAS RECEIVED A THE MANUFACTURING SITE AND IS MISSING A PIECE OF THE LENS, AND A HAPTIC. THE BROKEN SECTION OF THE LENS WAS NOT RETURNED. A LARGE SCRATCH ACROSS THE OPTICAL BODY WAS OBSERVED. TWO (2) SMALL STAINS THAT APPEARS TO BE OVD (OPHTHALMIC VISCOSURGICAL DEVICE) AND/OR BALANCED SALT SOLUTION WERE OBSERVED. THE RESULTS FOUND SUGGEST HANDLING OF THE PRODUCT AT THE SURGICAL SITE. THE LENS INSERT WAS EVALUATED AND NO DAMAGE WAS OBSERVED. BASED ON THE VISUAL EVALUATION, A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. HOWEVER, THE REPORTED ISSUE FOR A BROKEN HAPTIC WAS VERIFIED. THE CRACKED/TORN LENS WAS NOT VERIFIED; HOWEVER, LENS WAS SCRATCHED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW WAS PERFORMED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BROKEN HAPTICS AND CRACKED INTRAOCULAR LENS (MODEL ZA9003) WERE NOTICED WHEN THE LENS WAS ABOUT TO BE REMOVED FROM THE PACKAGE. NO PATIENT CONTACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481956 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZA9003 05050474528895

    Patients

    Seq Age Sex Outcome Treatment
    1