BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21947194 · Received May 1, 2025

    Report

    Report Number
    3012236936-2025-000110
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 1, 2025
    Report Date
    September 10, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655515
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 28-JUL-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT RETURNED. THE PLUNGER ROD WAS FOUND PARTIALLY ADVANCED. VISCOELASTIC RESIDUE WAS NOT OBSERVED TO BE EVENLY DISTRIBUTED THROUGHOUT THE CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED TO BE TORN AND DAMAGED; THE TEAR EXTENDED TO THE CARTRIDGE TUBE. THE LENS MODULE, DEVICE ASSEMBLY, PLUNGER ROD, AND PLUNGER ROD ADVANCEMENT WERE INSPECTED; NO ISSUES WERE OBSERVED. A CLEAR MATERIAL WAS RECEIVED INSIDE THE SPECIMEN CUP. ANALYSIS OF THE CLEAR MATERIAL WAS CONSISTENT WITH A MIXTURE CONTAINING AN ACRYLIC SPECIES AND POSSIBLY A VINYL POLYMER SIMILAR TO POLYVINYL PYRROLIDONE. THE FOURIER TRANSFORM INFRARED (FTIR) RAW DATA SPECTRUM WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY. THE RESULTS DID NOT FIND A COMPOUND MATCHING WITH AT LEAST A 0.9000 CORRELATION. THE TOP HIT WAS ¿3PC DRAGON LOOP¿ WITH A 0.6866 CORRELATION, AND "1PC EDGE BLOCKERS" WITH A 0.6729 CORRELATION. THE COMPLAINT ISSUE "FOREIGN MATERIAL-LOOSE" 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 COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, 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 - TELEPHONE NUMBER: (B)(6). 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF THE INJECTOR (1MM X 4MM) FOR A PRELOADED INTRAOCULAR LENS (IOL) DETACHED AND WAS INJECTED INTO THE PATIENT'S EYE AT THE SAME TIME AS THE IMPLANT, DESPITE THE PROPER PREPARATION OF THE IMPLANT. IT WAS NECESSARY TO REMOVE THE INTRAOCULAR FOREIGN BODY, WHICH WAS LOCATED BETWEEN THE IMPLANT AND THE POSTERIOR CAPSULE OF THE LENS. THE OPERATION TIME WAS EXTENDED BY 3 MINUTES FOR A SURGERY THAT TYPICALLY LASTS 15 MINUTES. TO DATE, THERE HAVE BEEN NO CLINICAL CONSEQUENCES FOR THE 74-YEAR-OLD FEMALE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023140 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655515

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female