BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19256105 · Received May 6, 2024

    Report

    Report Number
    3012236936-2024-000130
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    May 2, 2024
    Report Date
    August 27, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731806
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4, A5, PATIENT INFORMATION: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THEREFORE, NOT EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: 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, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & 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: (B)(6) 2024. SECTION H3: EVALUATED BY MANUFACTURER: YES . DEVICE EVALUATION: THE COMPLAINT DEVICE WAS RECEIVED. THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE COMPLAINT DEVICE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. THE PLUNGER ROD TIP WAS DAMAGED AND A HAPTIC WAS STUCK IN THE CARTRIDGE TIP AND OVERRIDDEN BY THE PLUNGER ROD. THE LENS MODULE WAS INSPECTED AND PRESENTED WITH NO DAMAGE OR VISCOELASTIC RESIDUE. THE DEVICE ASSEMBLY WAS INSPECTED AND PRESENTED WITH NO ISSUES. THE PLUNGER ROD ADVANCEMENT WAS INSPECTED AND NO RESISTANCE WAS FELT. THE LENS WAS REMOVED FROM THE TAPE. ONE HALF WAS RECEIVED AND THE HAPTIC WAS CUT. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A TRAILING HAPTIC THAT STUCK TO THE INSERTER. THE EVENT OCCURRED WHEN THE DOCTOR ATTEMPTED TO DEPLOY THE LENS INTO THE EYE/CAPSULE. THE IOL WAS REMOVED FROM THE RIGHT EYE IN PIECES. THERE WERE NO OTHER COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT OR SUTURES. THE CUSTOMER INDICATED THAT THE CARTRIDGE AND PART OF THE LENS ARE AVAILABLE FOR RETURN. THE IOL WAS REPLACED WITH ANOTHER JNJ LENS MODEL DIB00 22.0 DIOPTER. THE REPLACEMENT LENS WAS INSERTED WITHOUT DIFFICULTY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641680 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose