BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23375627 · Received October 23, 2025

    Report

    Report Number
    3012236936-2025-000265
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 17, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: OCTOBER 28, 2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION REVEALED A BLACK AND BROWN MATERIAL INSIDE THE VIAL. NO HANDPIECE OR LENS WAS RECEIVED FOR EVALUATION. THE VIAL AND FOREIGN MATERIAL WAS FURTHER ANALYZED AND THE MATERIAL WAS CONSISTENT WITH A CELLULOSIC MATERIAL (E.G. COTTON, RAYON, LINT). THE FOURIER TRANSFORM INFRARED (FTIR) SPECTRUM RAW DATA OUTPUT FILE GENERATED WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY. THE ANALYSIS DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.9000 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. 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 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 DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, 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: ADDITIONAL INFORMATION WAS PROVIDED AND IT WAS LEARNED THAT THE PATIENT IS A 78-YEAR-OLD MALE AND THE IOL WAS IMPLANTED IN THE PATIENT'S LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED. CORRECTED DATA: THEREFORE, THE FOLLOWING FIELDS HAVE BEEN UPDATED: SECTION AGE AT TIME OF THE EVENT: 78 YEARS. SECTION A3A. SEX: ENTER THE PATIENT'S SEX AT BIRTH (THE SEX THAT A PERSON HAS OR WAS ASSIGNED TO AT BIRTH): MALE. 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 BLACK FIBROUS FOREIGN MATERIAL WAS OBSERVED WHEN THE PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND UNFOLDED. THE PHYSICIAN REMOVED THE FOREIGN MATERIAL AND NO PATIENT INJURY WAS REPORTED. NO OTHER INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698565 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636712

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male