BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 9881612 · Received March 25, 2020

    Report

    Report Number
    2648035-2020-00279
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474530027
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 4/3/2020. SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED AND REVEALED NO DAMAGED AND/OR DEFECTS OBSERVED ON CARTRIDGES. HOWEVER, THREE SAMPLES WERE SENT TO EAG LAB (THIRD PARTY LAB) TO CHARACTERIZE THE FILM LIKE SUBSTANCE ON THE CARTRIDGE AND INSIDE THE CARTRIDGE TUBE/TIP FOR ALL THREE SAMPLES. EAG LAB RESULTS: EAG LAB RESULTS REVEALED THAT THE SUBSTANCE IS CONSISTENT WITH AN ALIPHATIC ESTER SIMILAR TO GLYCEROL MONOSTEARATE (GMS). IN POLYMER (PLASTICS) APPLICATION, GMS IS USED AS A LUBRICANT, ANTI-STATIC AND RELEASE AGENT AND NON-TOXIC PLASTICIZER. INVESTIGATION WAS EVALUATED WITH SME (SUBJECT MATTER EXPERT) TO ADDRESS THE COMPLAINT ISSUE REPORTED. BASED ON THE RESULTS OF THE EVALUATION OF THE UNITS, THERE IS NOT ENOUGH INFORMATION RECEIVED IN ORDER TO CONFIRM IF THE FILM/FOREIGN MATERIAL OBSERVED ON THE LENS IS GMS, SINCE IT WAS NOT RETURNED AND COULD NOT BE EVALUATED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED SIX ADDITIONAL COMPLAINT FOLDERS RECEIVED FROM THIS PRODUCTION ORDER. PRO DUCT DEFICIENCY WAS NOT IDENTIFIED. 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER IS RETURNING THE ZA9003 INTRAOCULAR LENS (IOL) AND EMERALD CARTRIDGE DUE TO A COMPLAINT OF A "FILM" ON THE ZA9003. IT WAS STATED THAT THE CUSTOMER IS NOT SURE IF THE FILM IS ON THE LENS OR IF IT CAME FROM THE CARTRIDGE. IT WAS LEARNED THAT THE IOL HAD PATIENT CONTACT AND WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE CARTRIDGE SUSPECT PRODUCT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE IOL SUSPECT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340022 EMERALD SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALDC30 CE01194 05050474530027

    Patients

    Seq Age Sex Outcome Treatment
    1 ZA9003 LENS SN: (B)(6)| ZA9003 LENS SN: (B)(4)