BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22846176 · Received August 19, 2025

    Report

    Report Number
    3012236936-2025-000214
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 11, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636750
    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, A5 AND A6: 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. 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: 06-AUG-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED. THE PLUNGER ROD WAS FOUND FULLY ADVANCED. VISCOELASTIC RESIDUE WAS OBSERVED THROUGHOUT THE CARTRIDGE AND NO CARTRIDGE ISSUES WERE OBSERVED. THE LENS MODULE AND DEVICE ASSEMBLY INSPECTION FOUND NO ISSUES; HOWEVER, VISCOELASTIC RESIDUE WAS OBSERVED BELOW THE LENS MODULE. PLUNGER ROD INSPECTION AND ADVANCEMENT FOUND NO ISSUES. NO LENS WAS RECEIVED FOR EVALUATION AND NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE "DELIVERY ISSUE" AND "TRAILING HAPTIC NOT FOLDED" COULD NOT BE CONFIRMED DURING PRODUCT EVALUATION AS NO LENS WAS RECEIVED FOR EVALUATION, AND NO ISSUES WERE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE TRAILING HAPTIC EXTENDED AND WAS STUCK BETWEEN THE CARTRIDGE AND PLUNGER. THE HAPTIC WAS RELEASED BY THE DOCTOR AND THE IOL WAS IMPLANTED. 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
    1156081 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown