BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 10834661 · Received November 13, 2020

    Report

    Report Number
    2648035-2020-00848
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 1, 2020
    Report Date
    February 19, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558359
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D10 - RETURNED TO MANUFACTURER ON: 1/10/2021. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. SECTION H3 - DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE FOREIGN MATERIAL WAS RECEIVED ON 01-10-2021 AT AMO PUERTO RICO MANUFACTURING / JOHNSON AND JOHNSON SURGICAL VISION. THE WHITE PARTICLE WAS OBSERVED ON THE CARTRIDGE TIP CAP. THE FOREIGN MATERIAL WAS SENT TO EAG LAB FOR FURTHER ANALYSIS. THE MATERIAL WAS ANALYZED BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY AND RESULTS SHOWS THAT THIS MATERIAL IS CONSISTED WITH ABS. EVEN THOUGH THE ABS MATERIAL IS PART OF THE PLUNGER COMPONENT, IT IS NOT POSSIBLE TO DETERMINED THAT THIS PARTICLE BELONGS TO IT SINCE THE PRELOADED DEVICE ARE NOT AVAILABLE FOR A THOROUGHLY EVALUATION. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. HOWEVER, THROUGHOUT THE MANUFACTURING PROCESS THERE ARE VARIOUS PROCESS CONTROLS STEPS THAT WILL IDENTIFY AND DISCARD A UNIT WITH ¿DC-FOREIGN MATERIAL ¿ LOOSE¿ CONDITION. BASED ON THE STATED ABOVE, THE MANUFACTURING PROCESS HAVE CONTROLS TO IDENTIFY AND DISCARD UNITS WITH ¿DEBRIS/PARTICULATES¿ AND DEVICES ARE PROCESSED WITHIN A CLASSIFIED CONTROLLED ENVIRONMENT. BASED ON THE FOREIGN MATERIAL RESULTS AND THE MANUFACTURING CONTROLS IN-PLACE, IT IS NOT POSSIBLE TO CONFIRM IF THE FOREIGN MATERIAL OBSERVED IS RELATED TO THE MANUFACTURING PROCESS, AS THE REPORTED UNITS WERE HANDLED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION.  A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. PHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION A SMALL, WHITE PLASTIC PIECE WAS INTRODUCED INTO THE EYE TOGETHER WITH THE TRAILING HAPTIC. IT WAS REMOVED AND KEPT WITHOUT ANY COMPLICATIONS. NO ISSUES FOR THE PATIENT NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299797 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558359

    Patients

    Seq Age Sex Outcome Treatment
    1