BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21329510 · Received February 6, 2025

    Report

    Report Number
    3012236936-2025-000027
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 6, 2025
    Report Date
    June 12, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474747166
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. 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: THROUGH FOLLOW-UP THE CUSTOMER PROVIDED ADDITIONAL DETAILS. THIS CURRENT REPORT IS TO PROVIDE THIS INFORMATION. THE CUSTOMER CLARIFIED THAT DURING THE EXPLANT OF THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL) THERE WAS AN ANTERIOR CAPSULE RENT WHICH LIKELY EXTENDED POST-OPERATIVELY. THERE WAS NO UNPLANNED VITRECTOMY. THE JNJ LENS WAS REMOVED FROM THE PATIENT¿S LEFT EYE AND REPLACED WITH A NEW ONE USING THE YAMANE TECHNIQUE. SUTURES WERE REQUIRED. NO FURTHER INFORMATION REGARDING THE EVENT WAS PROVIDED. SECTION A3A, SEX: FEMALE. SECTION A3B, GENDER: THE CUSTOMER RESPONDED ¿CISGENDER¿. SECTION A6, RACE: THE CUSTOMER RESPONDED ¿CAUCASIAN¿. SECTION A5, ETHNICITY: NOT HISPANIC/LATINO. SECTION H6- HEALTH EFFECT - CLINICAL CODE: 2639 USED TO CAPTURE THE ANTERIOR CAPSULE RENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP, THE CUSTOMER PROVIDED THE FOLLOWING CLARIFYING INFORMATION. THE CAPSULE TORE POSTOPERATIVELY ONCE THE INITIAL IOL WAS IMPLANTED. THE CAPSULE RENT LIKELY PROGRESSED WHILE TRYING TO ROTATE THE INITIAL LENS INTO POSITION. THUS, THE RENT OCCURRED PRIOR TO THE SECOND PROCEDURE. RESULTING IN THE INITIAL LENS BEING DISLOCATED AND NEEDING TO BE TAKEN OUT AND REPLACED. THE ANTERIOR CAPSULE TEAR (DUE TO THE INITIAL JOHNSON AND JOHNSON LENS) CAUSED A VITREOUS PROLAPSE WHICH NEEDED TO BE CLEARED PRIOR TO PLACING THE NEW LENS. THE REPLACEMENT IOL IS A NON-JOHNSON AND JOHNSON LENS MODEL CT LUCIA 602 +21.0. SUTURES WERE NOT NEEDED. NO FURTHER INFORMATION WAS PROVIDED. SECTION H6- HEALTH EFFECT - IMPACT CODE: 4625 USED TO CAPTURE THE VITRECTOMY. 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: APR 4, 2025 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE COMPLAINT INTRAOCULAR LENS (IOL) WAS RECEIVED. THE LENS WAS VISUALLY INSPECTED UNDER MAGNIFICATION REVEALING THAT THE LENS WAS CUT. SCRATCHES WERE ALSO OBSERVED ON THE SURFACE OF THE LENS. NO FURTHER ISSUES WERE IDENTIFIED. 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 PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DISLOCATED POST IMPLANTATION. THE IOL WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299054 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474747166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention