BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 25156944 · Received May 13, 2026

    Report

    Report Number
    3012236936-2026-000132
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 13, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531710
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. THEREFORE, IT WAS NOT EXPLANTED. SECTION E1: ADDRESS, CITY, STATE AND ZIP CODE: UNKNOWN/NOT PROVIDED. SECTION E1, TELEPHONE NUMBER: 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 AND COMPLAINT TRENDING 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). DURING A SURGICAL PROCEDURE PERFORMED ON A PATIENT THE TREATING DOCTOR REPORTED THAT AT THE MOMENT OF IMPLANTING THE INTRAOCULAR LENS INTO THE ANTERIOR CHAMBER, FOLLOWING THE INJECTION OF THE DEVICE THROUGH THE CARTRIDGE, IT WAS OBSERVED THAT ONE OF THE HAPTICS REMAINED ADHERED TO THE OPTICAL BODY OF THE LENS. DESPITE PERFORMING INTRAOPERATIVE MANEUVERS TO FACILITATE THE DEPLOYMENT OF THE IOL, IT WAS NOT POSSIBLE TO RELEASE THE HAPTIC OR CORRECTLY IMPLANT THE DEVICE, THEREBY RENDERING ITS PROPER POSITIONING IMPOSSIBLE. REPORTEDLY, THE PACKAGING WAS CHECKED AND SHOWED NO SIGNS OF DAMAGE. THE EXPIRATION DATE WAS CURRENT. NO FURTHER INFORMATION WAS PROVIDED. NOTE. THE CUSTOMER INADVERTENTLY SUBMITTED TWO DIFFERENT SERIAL NUMBERS FOR THE SAME EVENT. THE SERIAL NUMBER LISTED IN THE EMAIL SUBJECT LINE DOES NOT MATCH THE SERIAL NUMBER FOUND IN THE ATTACHED DOCUMENTATION. BOTH SERIAL NUMBERS WERE REPORTED AS FOLLOWS: (B)(6) MANUFACTURER REPORT NUMBER (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2026-0001323.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225803 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown