BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17847967 · Received September 29, 2023

    Report

    Report Number
    3012236936-2023-02477
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    August 28, 2023
    Report Date
    November 2, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731752
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. HENCE, NOT EXPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5: ADDITIONAL INFORMATION RECEIVED WITH THE RETURNED DEVICE INDICATED THAT THE LENS WAS FOR THE PATIENT'S RIGHT EYE. SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: OCT 10, 2023 SECTION H3. DEVICE EVALUATED MANUFACTURER? YES DEVICE EVALUATION: THE RETURNED DEVICE WAS EVALUATED. VISUAL INSPECTION REVEAL THAT THE COMPLAINT HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD ADVANCED TO THE LENS IN THE CARTRIDGE TIP AND THE LENS STUCK INSIDE OF THE CARTRIDGE TIP. THE LENS MODULE WAS INSPECTED, AND NO VISCOELASTIC RESIDUE OR WITNESS MARKS COULD BE IDENTIFIED IN THE MODULE. INSPECTION OF THE CARTRIDGE REVEAL THAT THERE WAS NOT VISCOELASTIC RESIDUE DISPERSED THROUGHOUT THE LENGTH OF THE CARTRIDGE, SUGGESTING THAT AN INADEQUATE AMOUNT OF OPHTHALMIC VISCOELASTIC DEVICE (OVD)/BALANCED SALT SOLUTION (BSS) MAY HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. THE LENS WAS REMOVED FROM THE CARTRIDGE AND CLEANED, REVEALING THAT THE LENS HAD A DETACHED HAPTIC. THE IOL COULD ALSO BE OBSERVED TO BE DAMAGED IN A WAY CONSISTENT WITH A LENS THAT WAS REMOVED FROM THE CARTRIDGE. THE HANDPIECE WAS DISASSEMBLED TO INSPECT ASSEMBLY, AND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. THE COMPLAINT ISSUE "LENS DAMAGED" 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. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING OF PRODUCT PACKAGING, THE MONOFOCAL INTRAOCULAR LENS (IOL) NOTED TO BE DEFECTIVE. THERE WAS NO CONTACT WITH THE PATIENT¿S EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353244 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown