BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7198594 · Received January 17, 2018

    Report

    Report Number
    2648035-2018-00127
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 19, 2017
    Report Date
    April 22, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474558366
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT AT THE 1 MONTH POST-OP VISIT, THE PARTICLE COULD STILL BE SEEN ON THE SLIT LAMP. THE PATIENT DOES NOT COMPLAIN ABOUT IT BUT IT BOTHERS HIM BECAUSE HE CAN SEE IT. NO INFLAMMATION WAS REPORTED. REPORTEDLY, THERE WAS NO RESISTANCE OR ISSUES WITH DELIVERY OF THE INTRAOCULAR LENS (IOL) DURING THE IMPLANTATION OF THE IOL. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON 02/21/2018. DEVICE EVALUATION: THE DEVICE (PCB00 INSERTION DEVICE) WAS RETURNED AND ANALYZED BY R&D (RESEARCH & DEVELOPMENT) CHEMISTRY AND MEDICAL EVENTS. THE OBJECTIVE OF THE EVALUATION WAS TO ATTEMPT TO IDENTIFY ANY ATYPICAL DEBRIS/FILM ON A RETURNED PCB00 INJECTOR SYSTEM. RESULTS REVEALED THERE WAS NO WHITE PARTICLE IDENTIFIED, AND NO ATYPICAL MOLECULES IDENTIFIED IN THE PCB00 RETURNED. THE PARTICLE IN ISSUE WAS NOT RETURNED, STILL INSIDE THE PATIENT EYE WITH THE LENS AS PER INFORMATION FROM THE CUSTOMER. AFTER COMPLETION OF THIS EVALUATION, THE SAMPLE WAS SEND TO THE MANUFACTURING SITE AND WAS EVALUATED. THE PLUNGER COMPONENT WAS NOT IN THE DEVICE BUT THE PUSHROD AND NUT WERE INSIDE THE SYSTEM. THE NUT IS A WHITE COMPONENT BUT DID NOT SHOW ANY DAMAGED NEITHER THE PUSHROD. THERE WERE OBSERVED RESIDUES AT THE CARTRIDGE TIP THAT WERE ASSOCIATED TO VISCOELASTIC RESIDUES INSTEAD DEBRIS AS IT WAS CONFIRMED IN THE R&D EVALUATION. IN ADDITION, NO DAMAGES IN THE CARTRIDGE WERE OBSERVED. THERE WERE NO PARTICLE/DEBRIS ISSUES IDENTIFIED IN THE DEVICE. THE DEVICE WAS RETURNED WAS INCOMPLETE FOR EVALUATION. HOWEVER, THE LENS WAS DEPLOYED; THEREFORE, THE COMPONENT SHOULD HAVE BE ASSEMBLED AS THE DEVICE REQUIRES. BASED ON THE EVALUATION RESULTS, THE COMPLAINT REPORTED AS PARTICLE/DEBRIS ISSUE WAS NOT CONFIRMED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED PER SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER NUMBER REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPT(S) HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (MODEL PCB00), THE SURGEON SAW ONE VERY SMALL SPOT ON THE LENS. NO INTERVENTION WAS REQUIRED AND THE LENS WAS LEFT IN THE PATIENT'S EYE. REPORTEDLY, THE SURGEON WAS NOT CONCERNED ABOUT IT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44795 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00 05050474558366

    Patients

    Seq Age Sex Outcome Treatment
    1