BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18296639 · Received December 8, 2023

    Report

    Report Number
    3012236936-2023-03132
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    December 6, 2022
    Report Date
    January 23, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 12/11/2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS RECEIVED IN A SPECIMEN CUP AND WAS CUT IN HALF WITH THE TWO PIECES. BOTH PIECES WERE STUCK TOGETHER. THE LENS WAS CLEANED AND PRESENTED WITH NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT EVENT. CONCLUSION: THE COMPLAINT ISSUE VISUAL DISTURBANCE- DYSPHOTOPSIA, HALO VISION, UNEXPECTED POSTOP REFRACTION, AND EXPLANT WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED. SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TECNIS PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO RING DYSPHOTOPSIA. THERE WAS NO PATIENT INJURY, NO VITRECTOMY AND NO INCISION ENLARGEMENT TO REMOVE THE LENS. PATIENT HAD LIMBAL RELAXATION INCISIONS (LRI). THE ORIGINAL LENS WAS REPLACED WITH LENS FROM ANOTHER MANUFACTURER. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD PRE-OPERATIVE ASTIGMATISM AND LIMBAL RELAXATIONS INCISIONS WAS DONE TO CORRECT ASTIGMATISM. PRE-OP BEST CORRECTED VISUAL ACUITY WAS PROVIDED AS +0.50-1.50X118, NO ACUITY WRITTEN IN CHART. POST-OP (POST-INITIAL IMPLANT) BEST CORRECTED VISUAL ACUITY WAS 20/40 ON DECEMBER 6, 2022. POST-OP (POST-REPLACEMENT IMPLANT) BEST CORRECTED VISUAL ACUITY WAS 20/25 ON (B)(6) 2023. INTENDED/TARGETED POST-OPERATIVE REFRACTION (FOR INITIAL IMPLANT) WAS STATED AS NO REFRACTION DONE S/P IOL EXCHANGE OD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273972 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention