BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20093270 · Received August 29, 2024

    Report

    Report Number
    3012236936-2024-000239
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 11, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. SECTION H3 (NO): THE DEVICE WAS NOT RETURNED FOR EVALUATION (THE LENS REMAINS IMPLANTED); 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. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DOCTOR'S OFFICE PHONE NUMBER IS +1(802)388-6565. SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT IT WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. NO FOREIGN MATERIAL WAS IDENTIFIED VIA EXTERNAL EVALUATION. THE LENS MODULE WAS INSPECTED AND NO FOREIGN MATERIAL WAS IDENTIFIED. THE BAG WAS INSPECTED AND A BLUE FIBER WAS IDENTIFIED INSIDE THE CIRCLE. THE BAG WAS FORWARDED TO AN EXTERNAL LABORATORY FOR FURTHER EVALUATION. PER THE EXTERNAL LABORATORY, THE MATERIAL IS A CELLULOSE SPECIES (E.G., COTTON, RAYON, LINT). THE FOURIER TRANSFORM INFRARED (FTIR) SPECTRUM RAW DATA OUTPUT FILE GENERATED BY THE EXTERNAL LABORATORY WAS THEN COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE TOP HIT WAS ¿TWT604NON WOVEN WIPES¿ WITH A 0.708388 CORRELATION. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED ONE ADDITIONAL COMPLAINT FOLDER WAS RECEIVED FOR THIS PO. HOWEVER, COMPLAINT ISSUES REPORTED ARE NOT RELATED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. CORRECTED DATA: THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY TO CAPTURE THE CORRECT PHONE NUMBER: SECTION E1: INITIAL REPORTER'S PHONE NUMBER: +(B)(6) ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THE DATE (AUG 22, 2024) WHICH THE DEVICE WAS RETURNED TO MANUFACTURER INADVERTENTLY WAS NOT ENTERED IN THE SECTION "H11" OF THE FOLLOW UP MDR REPORT #1; THEREFORE, THE INFORMATION HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AS INDICATED BELOW: SECTION D9: RETURNED TO MANUFACTURER ON: AUG 22, 2024. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE LEFT EYE OF A PATIENT AND NOTED BY THE DOCTOR TO HAVE A FOREIGN BODY WHICH WAS REMOVED FROM THE EYE. NO HARM TO PATIENT DUE TO REMOVAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179419 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown