BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23319206 · Received October 16, 2025

    Report

    Report Number
    3012236936-2025-000260
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 16, 2025
    Report Date
    December 11, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636705
    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 21, 2025 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. VISCOELASTIC RESIDUE WAS OBSERVED THROUGHOUT THE CARTRIDGE; CLUMPS OF A TRANSPARENT MATERIAL WAS OBSERVED INSIDE THE CARTRIDGE. STRESS MARKS WERE OBSERVED ON THE CARTRIDGE TIP BUT WERE IN SPECIFICATION FOR A USED DEVICE. NO ISSUES WERE OBSERVED WITH THE LENS MODULE, DEVICE ASSEMBLY, OR PLUNGER ROD ADVANCEMENT. THE PLUNGER ROD TIP WAS BENT. NO LENS WAS RECEIVED FOR EVALUATION. THE MATERIAL WAS NOT ORGANIC OR WAS INFRARED INACTIVE; THE MATERIAL WAS NOT REASONABLY IDENTIFIED BY FOURIER TRANSFORM INFRARED (FTIR). THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND 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 A3B, A4, AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A TRANSPARENT FOREIGN BODY WAS FOUND ATTACHED TO THE OPTICAL PART. IT WAS REMOVED USING FORCEPS, AND IRRIGATION AND ASPIRATION. ACCOUNT INDICATED THAT THE PATIENT WAS FEELING UNWELL AT THE END OF THE SURGERY. THE PATIENT'S FACE TURNED PALE BLUE ON THE NIGHT OF THE PROCEDURE AND THEY VOMITED REPEATEDLY. LATER, THE PATIENT WAS TAKEN TO THE EMERGENCY HOSPITAL AFTER TURNING PALE AND VOMITING DURING AN OPHTHALMOLOGY CONSULTATION. THE PATIENT'S INTRAOCULAR PRESSURE WAS NOT ELEVATED, AND THERE WERE NO RETINAL ABNORMALITIES. THE PATIENT HAS A HISTORY OF HYPERTENSION. SINCE THE PATIENT WAS REFERRED FROM A NEARBY OPHTHALMOLOGY CLINIC, THE PATIENT RETURNED TO THE REFERRING CLINIC. NO PATIENT INJURY WAS REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252381 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636705

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male