BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TECNIS SYNERGY

    MDR report key: 23000469 · Received September 9, 2025

    Report

    Report Number
    3012236936-2025-000229
    Event Type
    Injury
    Date Received
    September 9, 2025
    Report Date
    November 7, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE REPORTED EVENT WAS RE-EVALUATED AND THE CODING SUBMITTED SEPTEMBER 8TH 2025 IN REPORT 3012236936-2025-0002296 WAS AMENDED. 2137 - BLURRED VISION AND 2047 - RETINAL DETACHMENT WERE REMOVED AND THE FOLLOWING CODES HAVE BEEN ADDED: SECTION H6 - HEALTH EFFECT - CLINICAL CODE: 2138 - VISUAL IMPAIRMENT. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581 - NO CODE AVAILABLE (DEVICE DISLOCATION). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTIONS A3B, A4 AND A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. THE SURGERY TOOK PLACE IN 2021 AND THE ARTICLE ACCEPTANCE DATE IS (B)(6) 2025. SECTION D4 - CATALOG AND MODEL NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION H3: THE INTRAOCULAR LENS WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4625 FOR SECONDARY SURGICAL INTERVENTION AND UNPLANNED VITRECTOMY. CITATION: NAGAMOTO T, BAN N, KUBONO H, SUZUKI K, NEGISHI K. RE-FIXATION USING THE BELT LOOP TECHNIQUE FOR POSTOPERATIVE SUBLUXATION OF A MULTIFOCAL INTRAOCULAR LENS AFTER RETINAL DETACHMENT SURGERY: A CASE REPORT. CUREUS. 2025 FEB 24;17(2):E79585. DOI: 10.7759/CUREUS.79585. PMID: 40161112; PMCID: PMC11952161. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: RE-FIXATION USING THE BELT LOOP TECHNIQUE FOR POSTOPERATIVE SUBLUXATION OF A MULTIFOCAL INTRAOCULAR LENS AFTER RETINAL DETACHMENT SURGERY: A CASE REPORT. A CASE REPORT WAS DONE TO DESCRIBE A CASE OF MULTIFOCAL INTRAOCULAR LENS (MFIOL) SUBLUXATION AFTER MACULAR-OFF RHEGMATOGENOUS RETINAL DETACHMENT (RRD) FIXED BY THE BELT LOOP TECHNIQUE (BLT) NEEDLE EXTERNALIZATION APPROACH TO BILATERAL HAPTICS, IN WHICH GOOD VISUAL ACUITY WAS OBTAINED. A PATIENT UNDERWENT BILATERAL CATARACT SURGERY AND WAS INSERTED WITH TECNIS SYNERGY® (JOHNSON & JOHNSON VISION, (B)(6), USA) +12.0D IN THE RIGHT EYE, INTENSITY ((B)(6), (B)(6)) +12.5D IN THE LEFT EYE, AND CAPSULAR TENSION RINGS IN BOTH EYES. THE EYE IMPLANTED WITH THE TECNIS SYNERGY LENS WAS REPORTED TO DEVELOP A MACULA-OFF RETINAL DETACHMENT, PROMPTING PPV. 2 MONTHS AFTER PPV, THERE WAS NOTE OF DECREASED VISUAL ACUITY AND IOL SUBLUXATION, WHICH NECESSITATED AN IOL REPOSITIONING AND FIXATION USING THE BELT LOOP TECHNIQUE, WHICH IS AN OFF-LABEL PROCEDURE FOR FIXATION OF THE TECNIS SYNERGY IOL. A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496555 UNK_TECNIS SYNERGY INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention