BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_MONOFOCAL IOL

    MDR report key: 14432214 · Received May 18, 2022

    Report

    Report Number
    3012236936-2022-01284
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Report Date
    May 17, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN/NOT PROVIDED. BRAND NAME: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. PRODUCT CODE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DATE IMPLANTED: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. DATE EXPLANTED: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. PMA/510(K) NUMBER: UNKNOWN, AS IOL PRODUCT SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED. THEREFORE; NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND EXTENT OF PATIENT CONTACT IS UNKNOWN. THE PRODUCT HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186135 UNK_MONOFOCAL IOL MONOFOCAL IOL HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown