BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 19464460 · Received June 4, 2024

    Report

    Report Number
    3012236936-2024-000148
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Report Date
    June 19, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474529045
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION D6A - IMPLANT DATE: UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: UNKNOWN/NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: +(B)(6). SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE 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 · 0

    ADDITIONAL INFORMATION AND CORRECTED DATA THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. SECTION B5 - DESCRIBE EVENT OR PROBLEM: FURTHER FOLLOW-UP REVEALED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS BENT DUE TO THE NURSE MANIPULATION. SECTION H6 - MEDICAL DEVICE PROBLEM CODE: 1670 - USE OF DEVICE PROBLEM UPON FURTHER REVIEW OF THE NEW INFORMATION RECEIVED IT WAS DETERMINED THAT THE REPORTED INCIDENT DOES NOT CONSTITUTE A MALFUNCTION THAT COULD CAUSE A DEBILITATING CONDITION AS THE INCIDENT OCCURRED DUE TO USER ERROR. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER MFR REPORT NUMBER 3012236936-2024-0001488. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) HAD A BENT HAPTIC. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295196 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474529045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose