BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19732102 · Received July 12, 2024

    Report

    Report Number
    3012236936-2024-000195
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 29, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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, COMPLAINT TRENDING, AND RISK DOCUMENTATION 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. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581: DEVICE DISLOCATED. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE 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: JULY 9, 2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES . DEVICE EVALUATION: PHOTOGRAPHS PROVIDED BY THE CUSTOMER WERE EVALUATED. THE PICTURES SHOWED A PSEUDOPHAKIC EYE IMPLANTED WITH A LENS CLAIMED TO BE A TECNIS MONOFOCAL OPTIBLUE INTRAOCULAR LENS (IOL) PRELOADED IN A SIMPLICITY DELIVERY SYSTEM, MODEL DCB00V. OBSERVED WAS A WHITENING FIBROTIC-LIKE MATERIAL THAT APPEARED TO BE LOCATED POSTERIOR TO THE IOL AND TO ARISE FROM THE CAPSULAR TISSUE. ALTHOUGH IT IS EXPECTED THAT THE OBSERVED CAPSULE OPACIFICATION/FIBROSIS MAY CAUSE DECREASED VISUAL FUNCTION, THE ACTUAL CLINICAL/VISUAL IMPACT OR POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED FROM A PICTURE ASSESSMENT. VISUAL INSPECTION WAS PERFORMED ON THE LENS. THE COMPLAINT DEVICE WAS CLEANED AND PRESENTED OPAQUE. THE LENS WAS CUT AND THE EDGE OF THE OPTIC BODY WAS DAMAGED. THE CUSTOMER'S PHOTOGRAPH AND VIDEO WERE FURTHER EVALUATED. THE SHAPE AND SIZE OF THE CIRCULAR PERFORATIONS OBSERVED WAS DETERMINED TO BE INCONSISTENT WITH THE SIZE AND SHAPE OF THE PUSHROD TIP USED TO DELIVER A LENS. THE SIZE AND SHAPE OF THE GRIPPER USED TO GRASP THE EDGE OF THE LENS APPEARED TO BE MORE REPRESENTATIVE OF A TOOL THAT COULD HAVE CAUSED THE PERFORATIONS OBSERVED ON THE EDGE OF THE LENS. THE GRIPPER WAS OBSERVED TO HAVE GRASPED THE LENS IN THE LOCATIONS SUBSEQUENTLY EXHIBITED IN THE CIRCULAR PERFORATIONS. IT DID NOT APPEAR THAT THE SIMPLICITY HANDPIECE CREATED THE DAMAGES OBSERVED ON THE POSTERIOR SURFACE OF THE EDGE OF THE LENS. THE COMPLAINT ISSUE "LENS DAMAGED" WAS IDENTIFIED DURING PRODUCT AND PHOTOGRAPH/VIDEO 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. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATION. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE FOUND, AND NO ESCALATION WAS REQUIRED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN (B)(6) 2021 AND THE IOL DISLOCATED (FELL) IN THE EYE. AT THE TIME, THE CASE SEEMED TO BE ASSOCIATED WITH AN ANTERIOR CAPSULE CALCIFICATION, BUT THE IOL WAS NORMALLY FIXED IN THE CAPSULE. SUBSEQUENTLY, DURING A SECONDARY SURGERY TO RECOVER THE IOL DISLOCATION, IT WAS NOTICED THAT THE EDGE OF THE IOL'S OPTIC WAS FINELY BROKEN. THE PHYSICIAN CONSIDERED THE CAUSE OF THIS EVENT TO BE AS FOLLOWS: THE DEAD BAG SYNDROME (A CONDITION OF INTRAOCULAR LENS DEVIATION IN WHICH THE LENS CAPSULE IS CLEAR AND THERE ARE ALMOST NO LENS EPITHELIAL CELLS IN THE CAPSULE IN THE LATE STAGE AFTER CATARACT SURGERY); THE CALCIFIED AREA SUDDENLY TORN AFTER THREE YEARS; THE IOL DISLOCATION WAS CAUSED BY BREAKAGE SEEN AT THE EDGE OF THE IOL OPTICS AND THERE IS A POSSIBILITY THAT THE POSTERIOR CAPSULE MIGHT HAVE BEEN DAMAGED BY THE VIT CUTTER DURING THE OPERATION, BUT IT IS UNLIKELY THAT A LARGE WOUND WOULD OCCUR BECAUSE 27G WAS USED. THROUGH FOLLOW-UP WE LEARNED THAT THE POSTERIOR CAPSULE BROKE AND THE IOL DISLOCATED INTO THE VITREOUS. AN IOL FROM ANOTHER MANUFACTURER WAS FIXED TO THE SCLERA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152118 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention