BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22294325 · Received June 19, 2025

    Report

    Report Number
    3012236936-2025-000156
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 19, 2025
    Report Date
    August 21, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS 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: JUNE 16, 2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: A VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT. THE LENS WAS FOUND STUCK IN THE CARTRIDGE. VISCOELASTIC RESIDUE WAS NOT OBSERVED TO BE DISTRIBUTED THROUGHOUT THE CARTRIDGE. THE CARTRIDGE WAS OBSERVED TO BE TORN, AND THE CARTRIDGE TIP WAS BENT AND DAMAGED. THE LENS MODULE AND DEVICE ASSEMBLY WERE INSPECTED REVEALING NO ISSUES. PLUNGER ROD ADVANCEMENT REVEALED NO RESISTANCE; THE PLUNGER ROD TIP WAS OBSERVED TO BE BENT UPWARDS. THE LENS COULD NOT BE REMOVED FROM THE CARTRIDGE FOR FURTHER EVALUATION. NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE "CARTRIDGE TIP CRACKED/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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE FOUND. 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 DOCTOR STOPPED USING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BECAUSE THERE WAS A HOLE IN THE CARTRIDGE TIP DURING IMPLANTATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE. NO PATIENT INJURY WAS REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT THE DEVICE WAS IN CONTACT WITH THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853004 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown