BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 14992261 · Received July 12, 2022

    Report

    Report Number
    3012236936-2022-01782
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Report Date
    August 24, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474654723
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE: UNKNOWN/ NOT PROVIDED. EXPLANT DATE: UNKNOWN/ NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: 08TH JULY 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT MATERIAL WAS RECEIVED IN A SPECIMEN CUP. THE MATERIAL WAS SENT TO EAG LABORATORIES FOR ANALYSIS. EAG LABORATORIES REPORTED THE MATERIAL TO BE POLYPROPYLENE AND AN ACRYLIC SPECIES, POSSIBLY ALSO WITH A VINYL POLYMER SIMILAR TO POLYVINYL PYRROLIDONE AND AN INORGANIC SPECIES SIMILAR TO SODIUM HYALURONATE. THE FOURIER INFRARED SPECTROSCOPY (FTIR) RESULTS WERE COMPARED TO THE MANUFACTURING SITE FTIR DATABASE AND NO SAMPLES PASSED THE 0.9 CORRELATION THRESHOLD. THE CLOSEST MATCH TO THE DATABASE WAS LISTED AS 00080294 LENS CASE LABEL GLUE AND HAD A 0.68 CORRELATION. THE COMPLAINT ISSUE WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE EAG TESTING AND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER FOUND A PARTICLE IN THE LENS WHILE INSERTING IT. THE PARTICLE WAS REMOVED AND IS AVAILABLE. NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668476 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474654723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown