BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15108895 · Received July 26, 2022

    Report

    Report Number
    3012236936-2022-02021
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    July 2, 2022
    Report Date
    December 23, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474536197
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. IMPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. THEREFORE, LENS WAS NOT EXPLANTED. INITIAL REPORTER FIRST & LAST NAME: INFORMATION UNKNOWN/NOT PROVIDED. INITIAL REPORTER ADDRESS: INFORMATION UNKNOWN/NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT NOT PROVIDED. TELEPHONE NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: 12AUG 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. A ZMB00 LENS WITH SERIAL NUMBER (B)(6) WAS FOUND INSIDE A FOLDING CARTON WITH THE SERIAL NUMBER (B)(6). PATIENT STICKERS WITH THE SERIAL NUMBER (B)(6) WERE ALSO FOUND INSIDE THE (B)(6) FOLDING CARTON. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING PROCESS RECORD FOR PRODUCTION ORDER (B)(4) WAS EVALUATED FOR TECNIS MF 1- PIECE 6.0MM 19.0 INTL ZMB00 MODEL WITH SERIAL NUMBER RANGE (B)(6). THE PRODUCTION ORDER WAS MANUFACTURED ON JULY 03, 2021. THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW) RELATED TO THIS COMPLAINT. THE UNITS WERE RELEASED ACCORDING TO SPECIFICATION IN COMPLIANCE WITH THE PRODUCT INTENDED USE AS REQUIRED. THE LENS DIOPTER RESULT OBTAINED FROM THE MIQ ELECTRONIC SYSTEM OF THE TEST PERFORMED WHEN THIS LENS WAS MANUFACTURED, SHOWS THAT LENS SERIAL NUMBER (B)(6) BELONGS TO DIOPTER 19.0. THE LENS DIOPTER RESULT OBTAINED FROM THE MIQ ELECTRONIC SYSTEM OF THE TEST PERFORMED WHEN S/N: (B)(6) WAS MANUFACTURED, SHOWS THAT THIS LENS BELONGS TO DIOPTER 17.0. THE COMPLAINT EVENT DATE WAS ON JULY 02, 2022. COMPLAINT WAS CREATED AGAINST PO (B)(4)WHICH WAS MANUFACTURED A MONTH AFTER PO (B)(4) RELATED TO THIS COMPLAINT AS WELL. NO DEVIATIONS WERE FOUND DURING THE MIQ PROCESS FOR THESE POS. BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: BASED ON THE ASSESSMENT PERFORMED AND RECORDS REVIEWED, THE COMPLAINT WAS NOT CONFIRMED SINCE NO PRODUCT PROBLEM WAS IDENTIFIED. THERE ARE EXISTING CONTROLS WITHIN OUR MANUFACTURING PROCESS TO IDENTIFY AND DISCARD UNITS WITH ¿LABELING ISSUES¿. AS PART OF THE MANUFACTURING PROCESS, THE PRODUCT LABELS WITH THE UNIQUE IDENTIFICATION ARE PRINTED PER EACH PO DURING THE MANUFACTURING PROCESS, ARE 100% INSPECTED AGAINST THE PO INFORMATION, AND ARE PLACED AND/OR ASSEMBLED THROUGHOUT THE SPECIFIC REQUIRED OPERATION FOLLOWING THE PROCEDURES. THE SERIAL NUMBERS ARE ASSIGNED BY SAP (SYSTEM APPLICATION PRODUCTS) SYSTEM, PRINTED, AND PLACED TO THE DAISY WHEEL CASE THROUGHOUT MIQ OPERATION. THE FIRST AND LAST LABEL ARE RE-PRINTED AND PLACED INTO THE PO TRAVELER FOR TRACEABILITY. THE IOL BARCODED BOX LABEL, THE IMPLANT NOTIFICATION LABEL, PATIENT LABELS (INSERT LABELS/CHART LABELS) AND LENS IMPLANT PATIENT I.D. STICKER LABEL ARE GENERATED AND PRINTED BY SAP AS WELL. THEN, ALL THESE COMPONENTS ARE SCANNED (CREATING A SCAN REPORT AT THE SYSTEM FOR TRACEABILITY), IF A WRONG COMPONENT IS DETECTED OR IF IS SCAN A PREVIOUS SERIAL ALREADY SCANNED, THE SYSTEM STOP THE OPERATION AND SHOWS AN ERROR MESSAGE CREATING A SCAN LOG ERROR REPORT. AFTER ALL THESE COMPONENTS ARE INSIDE THE IOL PACKAGE BOX A TAMPER EVIDENT STICKER IS PLACED TO SEAL THE BOX. BASED ON THE EVALUATION RESULTS AND THE MANUFACTURING CONTROLS IN-PLACE AN ASSIGNABLE CAUSE COULD NOT BE TRACED BACK TO THE MANUFACTURING PROCESS. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AS MENTIONED ABOVE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTER PACKAGE INDICATED ZMB00 19.0D WITH SN (B)(4). HOWEVER, WHEN DOCTOR OPENED THE PACKAGE FOR SURGERY, IT WAS FOUND THAT THE INTRAOCULAR LENS (IOL) INSIDE INDICATED ZMB00 17.0D WITH SN (B)(4). THE LENS WAS NOT USED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433386 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZMB00 05050474536197

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown