BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZLB00

    MDR report key: 9537284 · Received January 2, 2020

    Report

    Report Number
    2648035-2020-00001
    Event Type
    Injury
    Date Received
    January 2, 2020
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: BASED ON RECEIVING NEW INFORMATION, THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY. PRODUCT CODE: MFK, COMMON DEVICE NAME: TECNIS MULTIFOCAL LENS; CATALOG #: ZLB00U0220, UNIQUE IDENTIFIER (UDI#): (B)(4), EXPIRATION DATE: 10/16/2022. PMA NUMBER#: P980040. DEVICE MANUFACTURE DATE: 10/16/2018. DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE; THEREFORE, THE COMPLAINT ISSUE REPORTED WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 3/3/2020. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED IN A LENS CASE FOR AN ALCON SA60WF MODEL LENS (SERIAL NUMBER: (B)(4), AND A DIOPTER OF 22.0D), AND A PLASTIC BAG WAS ALSO RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED CUT IN HALF (ONLY A LENS HALF AND FRAGMENT WAS RECEIVED), WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. ADDITIONALLY, VISCOELASTIC RESIDUE WAS OBSERVED ON THE OPTIC BODY AND HAPTIC. BASED ON THE CONDITION OF THE RETURN LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, IF EXPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. CATALOG #: CATALOG # IS UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI#): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. PMA NUMBER IS UNKNOWN AS PRODUCT IDENTIFIERS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO MODEL/LOT/SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ATTEMPTS HAVE MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNIDENTIFIED INTRAOCULAR LENS (MODEL UNKNOWN/NOT PROVIDED) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR THE EXCHANGE IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912 ZLB00 TECNIS 1 MULTIFOCAL MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention