BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7441600 · Received April 18, 2018

    Report

    Report Number
    2648035-2018-00539
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    January 24, 2018
    Report Date
    May 31, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531772
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 04/27/2018. DEVICE EVALUATION: THE COMPLAINT UNIT WAS RECEIVED IN A PLASTIC BAG WITH THE WHEEL CASE INSERT. VISUAL INSPECTION WAS PERFORMED: LOOSE PARTICLES WERE OBSERVED ON THE LENS SURFACE THAT COULD BE RELATED TO HANDLING OF THE PRODUCT IN NON-STERILE ENVIRONMENT. DEPRESSION MARK WAS OBSERVED ON THE LENS SURFACE. THE HAPTIC WAS SLIGHTLY DISTORTED. THE REPORTED ISSUES OF COSMETIC AND HAPTIC DAMAGED WERE VERIFIED. THE CONDITION IN WHICH THE SAMPLE WAS RECEIVED IS CONSISTENT WITH A UNIT THAT HAS BEEN PREVIOUSLY HANDLED. BASED ON THE ANALYSIS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT 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 COMPLAINT WAS RECEIVED FROM 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. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS SCRATCHED AND HAPTIC WAS BENT AND/OR BROKEN UPON OPENING THE PACKAGE. PER ACCOUNT, LENS WAS NOT SEATED IN PLASTIC CASE CORRECTLY AND WAS CRIMPED WHEN OPENING PACKAGE. THERE WAS NO PATIENT CONTACT. IOL WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND/OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283852 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531772

    Patients

    Seq Age Sex Outcome Treatment
    1