BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 17481867 · Received August 8, 2023

    Report

    Report Number
    3012236936-2023-01869
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    April 20, 2023
    Report Date
    August 8, 2023
    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
    003

    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 D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: +31 303 0744 0390 DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT SMARTLOAD WAS RECEIVED WITH THE CARTRIDGE AND CARTRIDGE TIP CRACKED. THE SMARTLOAD WAS DISASSEMBLED AND THE ASSEMBLY WAS INSPECTED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO OR CAUSE THE COMPLAINT/OBSERVED ISSUES. THE COMPLAINT ISSUE OF CARTRIDGE CRACK WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. 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 CARTRIDGE CRACKED DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL). LENS WAS IMPLANTED SUCCESSFULLY INTO THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW UP WE LEARNED THAT THERE WAS NO PATIENT INJURY. NO DELAY IN SURGERY WAS MENTIONED. PATIENT OUTCOME IS NOT NEGATIVELY INFLUENCED BY THE CRACK. THE PHYSICIAN FOLLOWED THE DIRECTIONS FOR USE (DFU) OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. INVESTIGATOR CONFIRMED THE CRACK WAS AT THE TIP OF THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814481 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474654723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown