BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16940405 · Received May 16, 2023

    Report

    Report Number
    3012236936-2023-01216
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    March 7, 2023
    Report Date
    September 28, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731738
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE CUSTOMER CONFIRMED THEY NOTICED THE IOL WAS DAMAGED AFTER IT WAS FULLY INSERTED INTO THE PATIENT¿S RIGHT EYE. IT WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON(JNJ) LENS OF THE SAME MODEL AND DIOPTER, SERIAL# (B)(6). THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES USED. NO NEED FOR MEDICATION OUTSIDE THE STANDARD OF CARE. CUSTOMER USED THE ALCON BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE. NO ADDITIVES WERE USED. REPORTEDLY, IT'S UNKNOWN IF THE BSS WAS INTRODUCED AT THE TIP OF THE CARTRIDGE OR THE CANOPY SECTION. CUSTOMER ALSO REPORTED AS UNKNOWN WHETHER THEY USED A COMBINATION OF BSS AND OVD (OPHTHALMIC VISCOSURGICAL DEVICE). IT WAS INDICATED THAT NEITHER PHOTOS OR VIDEOS OF THE DAMAGED LENS ARE AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. SECTION A2, DATE OF BIRTH: (B)(6) 1954. SECTION A3, GENDER: FEMALE SECTION E1, TITLE: DR. FIRST/GIVEN NAME: (B)(6). LAST NAME: (B)(6). SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D10, CONCOMITANT MEDICAL PRODUCTS: PRELOADED/BSS/ALCON SECTION E3, OCCUPATION: PHYSICIAN SECTION H6, HEALTH EFFECT-IMPACT CODE: 4631 CAPTURES THE UPDATED INFORMATION OF REMOVAL AND REPLACEMENT. CORRECTED DATA: IN REVIEW AND BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE CODE "2199 " THAT WAS ENTERED IN SECTION "H6 -HEALTH EFFECT - IMPACT CODE" OF THE INITIAL MDR REPORT NO LONGER IS APPLICABLE. PLEASE NOTE THAT THE INFORMATION REPORTED IN SECTIONS D2 (COMMON DEVICE NAME), H.6 (HEALTH EFFECT -CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE) AND SECTION G.1 (MANUFACTURER CONTACT E-MAIL) IS INFORMATION THAT REMAINS UNCHANGED FROM THE INITIAL EMDR REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: JUN 15, 2023 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE PRODUCT WAS RECEIVED AND EVALUATED. A 'SCUFF" MARK ON THE POSTERIOR OF THE IOL WAS OBSERVED. THE INSPECTION OF ALL ASSEMBLY RELATED ITEMS REVEALED NO ANOMALIES. NO ASSEMBLY ISSUES WERE IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A, PATIENT INFORMATION: A2, A4, A5: INFORMATION UNKNOWN/ASKU. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THE LENS WAS IMPLANTED. HENCE, NOT EXPLANTED. SECTION H3-OTHER (81): THE DEVICE HAS NOT BEEN 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED ¿NICK ON LENS¿ ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190051 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731738

    Patients

    Seq Age Sex Outcome Treatment
    1 Female PRELOADED/BSS/ALCON