BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8830794 · Received July 26, 2019

    Report

    Report Number
    3006695864-2019-00609
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 19, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531710
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATION: THE SAMPLE WAS RECEIVED AT SITE AND VISUAL INSPECTION WAS PERFORMED TO THE ZCB00 RETURNED AND THE FOLLOWING WERE THE OBSERVATIONS: VISCOELASTIC RESIDUES WERE FOUND IN LENS SURFACE. THE LENS WAS CUT IN TWO (2) PIECES. THE COMPLAINT ISSUE WAS NOT VERIFIED. BASED ON THE VISUAL EVALUATION OF THE RETURNED UNIT IT COULD NOT BE DETERMINED THAT THE CAUSE OF THE ISSUE REPORTED IS RELATED TO THE MANUFACTURING PROCESS SINCE THERE ARE INDICATIONS THE UNIT WAS HANDLED FOR LENS INSERTION AT THE SURGICAL STAGE AND EXPLANTED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 2648035. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A LOADING ERROR. IT WAS STATED THAT THERE WERE SUTURES PERFORMED. NEVERTHELESS, PATIENT WAS WELL POST-OP. IT WAS LEARNT DURING FOLLOW-UP THAT THE CONTACT PERSON DOESN'T KNOW THE SPECIFIC REASON FOR THE EXPLANT AS WELL AS IF THERE WERE ANY VISUAL ISSUES OR NOT. HOWEVER, THE CONTACT PERSON PROVIDED THE DOCTOR AND PATIENT IDENTIFIERS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624239 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531710

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention