BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 17015220 · Received May 26, 2023

    Report

    Report Number
    3012236936-2023-01247
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Report Date
    May 26, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: DATE UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4: CATALOG NUMBER: PARTIAL CATALOG NUMBER INDICATED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON INTRODUCED A METAL PARTICLE INTO THE PATIENT'S EYE WHEN IMPLANTING AN INTRAOCULAR LENS (IOL). THE PARTICLE WAS REMOVED FROM THE EYE. WE LEARNED THROUGH FOLLOW UP THAT THE EVENT DATE AND SERIAL NUMBER FOR THE LENS ARE UNKNOWN. IT IS UNKNOWN IF THE IOL REMAINS IMPLANTED AND THERE IS NO INFORMATION ON HOW THE PATIENT IS DOING NOW. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729682 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GAB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown