BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21910041 · Received April 25, 2025

    Report

    Report Number
    3012236936-2025-000100
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 23, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION WAS PROVIDED AND IT WAS LEARNED THAT THE FOREIGN MATERIAL APPEARED AS A FUZZY SUBSTANCE, SIMILAR TO OCULAR VISCOUS ELASTIC, WHICH WAS ADHERED TO THE UPPER SURFACE OF THE LENS'S OPTIC. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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 G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 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 THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING 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. 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: APRIL 21, 2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES . DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED TORN AT ONE OF THE HAPTIC/OPTIC JUNCTION; THE TORN PIECE REMAINED STUCK AT THE CARTRIDGE TIP. A MASS OF UNKNOWN MATERIAL WAS OBSERVED ON THE LENS. THE COMPLAINT HANDPIECE WAS OBSERVED WITH THE PLUNGER ROD ADVANCED TO THE TORN LENS PIECE. VISCOELASTIC RESIDUE WAS OBSERVED TO BE EVENLY DISTRIBUTED THROUGHOUT THE CARTRIDGE; STRESS MARKS WERE OBSERVED ON THE CARTRIDGE TIP BUT WERE IN SPECIFICATION FOR A USED DEVICE. NO CARTRIDGE OR CARTRIDGE TIP ISSUES WERE IDENTIFIED. THE LENS MODULE WAS INSPECTED REVEALING NO ISSUES. DEVICE ASSEMBLY WAS INSPECTED REVEALING NO ISSUES; VISCOELASTIC RESIDUE WAS OBSERVED BELOW THE LENS MODULE INDICATING THAT AN EXCESSIVE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) MAY HAVE BEEN USED. THE PLUNGER ROD AND PLUNGER ROD ADVANCEMENT WERE INSPECTED REVEALING NO ISSUES. THE LENS PORTION STUCK IN THE CARTRIDGE TIP COULD NOT BE REMOVED FOR FURTHER EVALUATION. THE MATERIAL IS A MIXTURE POSSIBLY CONTAINING SOME OR ALL OF THE FOLLOWING: A METHACRYLATE SPECIES, A VINYL POLYMER SIMILAR TO POLYVINYL PYRROLIDONE, AND SODIUM HYALURONATE. THE FOURIER TRANSFORM INFRARED (FTIR) SPECTRUM RAW DATA OUTPUT FILE GENERATED BY A THIRD PARTY LABORATORY WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY. THE ANALYSIS DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 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 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 WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED, AN OBJECT THAT APPEARED TO BE A FOREIGN MATERIAL WAS FOUND AROUND THE CENTER OF THE LENS, AND THE LENS INSERTION WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE. THERE WERE NO PATIENT INJURIES, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP WE LEARNED, THAT THE LENS WAS IN THE PATIENT'S EYE ONCE AND THEN REMOVED. THE FOREIGN MATERIAL WAS IN CONTACT WITH THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480422 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown