BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 21869145 · Received April 18, 2025

    Report

    Report Number
    3012236936-2025-000110
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531697
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND CORRECTION: ADDITIONAL INFORMATION RECEIVED ON 4/24/2025 STATED THAT THE SURGEON CONFIRMED THAT THE "BLACK DOTS FOUND ON THE SURFACE OF THE OPTIC¿ ARE NOT FOREIGN MATERIAL BECAUSE SHE TRIED TO REMOVE IT DURING THE SURGERY BUT NOTHING WAS IMPROVED. SO, SHE THOUGHT THIS ISSUE IS ASSOCIATED WITH LENS OPTIC ITSELF. THESE BLACK DOTS DID NOT LEAD TO VISUAL IMPAIRMENT AND PATIENT DOES NOT FEEL ANY DISCOMFORT AFTER SURGERY. DOCTOR DECIDED NOT TO EXCHANGE INTRAOCULAR LENS (IOL) SINCE THERE WAS NO VISUAL IMPAIRMENT. BASED ON ABOVE ADDITIONAL INFORMATION, THE EVENT IS ASSESSED AS NOT REPORTABLE. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2025-0001108. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A6: PATIENT INFORMATION NOT PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION E1: REPORTER EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAIN IMPLANTED IN THE EYE. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING 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 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

    INITIALLY REPORTED THAT SOME BLACK DOTS HAD BEEN FOUND ON THE SURFACE OF THE OPTIC OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) RIGHT AFTER IMPLANTATION AND THE SURGEON DECIDED NOT TO EXCHANGE IOL ON THE DAY BUT IOL EXCHANGE MAY HAPPEN DEPENDING ON THE PATIENT'S DISCOMFORT AND POST-OP RESULT. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 4/24/2025 STATED THAT THE SURGEON CONFIRMED THAT THE "BLACK DOTS FOUND ON THE SURFACE OF THE OPTIC¿ ARE NOT FOREIGN MATERIAL BECAUSE SHE TRIED TO REMOVE IT DURING THE SURGERY BUT NOTHING WAS IMPROVED. SO, SHE THOUGHT THIS ISSUE IS ASSOCIATED WITH LENS OPTIC ITSELF. THESE BLACK DOTS DID NOT LEAD TO VISUAL IMPAIRMENT AND PATIENT DOES NOT FEEL ANY DISCOMFORT AFTER SURGERY. DOCTOR DECIDED NOT TO EXCHANGE INTRAOCULAR LENS (IOL) SINCE THERE WAS NO VISUAL IMPAIRMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME BLACK DOTS HAD BEEN FOUND ON THE SURFACE OF THE OPTIC OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) RIGHT AFTER IMPLANTATION AND THE SURGEON DECIDED NOT TO EXCHANGE IOL ON THE DAY BUT IOL EXCHANGE MAY HAPPEN DEPENDING ON THE PATIENT'S DISCOMFORT AND POST-OP RESULT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20462 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown