BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 15664181 · Received October 24, 2022

    Report

    Report Number
    3012236936-2022-02644
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 30, 2022
    Report Date
    December 22, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620605
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: NO COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. A CUSTOMER PROVIDED PHOTO WAS RECEIVED AND EVALUATED IN WHICH THE ALLEGED FOREIGN MATTER CAN BE SEEN ON A PIECE OF MEDICAL GAUZE. HOWEVER, DUE TO THE MAGNIFICATION AND IMAGE QUALITY THE FOREIGN MATTER COULD NOT BE IDENTIFIED. DUE TO NO PRODUCT BEING RETURNED, NO FURTHER INFORMATION WAS PROVIDED. 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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 · 0

    PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. EXPLANT DATE: N/A, LENS REMAINS IMPLANTED. INITIAL REPORTER: TELEPHONE NUMBER: (B)(6). DEVICE EVALUATED BY MFR: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PRELOADED INTRAOCULAR LENS (IOL), A RING WAS FOUND IN THE EYE AND WAS REMOVED WITHOUT ANY CONSEQUENCES TO THE OUTCOME OF THE SURGERY. THE OPERATING THEATER STAFF DID NOT KEEP EITHER THE RING OR THE CARTRIDGE. THROUGH FOLLOW UP IT WAS VERIFIED THAT THE FOREIGN MATERIAL WAS INTRODUCED INTO THE EYE AND REMOVED IMMEDIATELY. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341981 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown