BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER EMERALD

    MDR report key: 21048627 · Received December 31, 2024

    Report

    Report Number
    3012236936-2024-000348
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    November 29, 2024
    Report Date
    May 13, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474530027
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: N/A, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: N/A, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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: THE DEVICE WAS NOT RETURNED; HOWEVER, A PICTURE THAT WAS PROVIDED WAS EVALUATED. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: A PHOTOGRAPH PROVIDED BY THE CUSTOMER WAS EVALUATED. THE PHOTOGRAPH DISPLAYED THE SUSPECT CARTRIDGE AND ONE CARTRIDGE WING CAN BE OBSERVED TO BE DETACHED. DUE TO THE QUALITY OF THE PHOTOGRAPH AND NO PRODUCT RECEIVED, NO FURTHER EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUES "HAPTIC DETACHED" AND "CARTRIDGE DAMAGED" WERE NOT IDENTIFIED DURING PHOTOGRAPH EVALUATION. THE OBSERVED "WING BROKEN" IS SIMILAR TO THE REPORTED COMPLAINT ISSUE "CARTRIDGE DAMAGED". 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 COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE IDENTIFIED. 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: MARCH 12, 2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE CARTRIDGE WAS EVALUATED UNDER MAGNIFICATION. THE CARTRIDGE WAS RECEIVED WITH VISCOELASTIC RESIDUE DISTRIBUTED THROUGH THE LENGTH OF THE CARTRIDGE. THE CARTRIDGE TIP WAS DAMAGED. THE COMPLAINT ISSUES "HAPTIC DETACHED" AND "CARTRIDGE DAMAGED" WERE NOT IDENTIFIED DURING PHOTOGRAPH AND PRODUCT EVALUATION. THE OBSERVED "CARTRIDGE TIP CRACKED/DAMAGED" IS SIMILAR TO THE REPORTED COMPLAINT ISSUE "CARTRIDGE DAMAGED". 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 COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION IDENTIFIED. 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 NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS DETACHED INSIDE THE INJECTOR DURING IMPLANTATION. THE INJECTOR WAS DEFECTIVE AND THE LENS WAS IN CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW-UP, WE LEARNED, THAT THE PATIENT IS WELL. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS WITH THE SAME DIOPTER. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED UNDER THE NUMBER 3012236936-2024-0003488 TO CAPTURE THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782518 UNFOLDER EMERALD LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. EMERALDC30 CP03436 05050474530027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown