BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 25338509 · Received May 29, 2026

    Report

    Report Number
    3012236936-2026-000141
    Event Type
    Injury
    Date Received
    May 29, 2026
    Report Date
    May 29, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS MARCH 7, 2025. SECTION D4: CATALOG NUMBER: PARTIAL NUMBER PROVIDED, AS THE SERIAL NUMBERS WERE NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBERS WERE NOT PROVIDED. SECTION D4: UDI NUMBER: PARTIAL NUMBER PROVIDED AS THE SERIAL NUMBERS WERE NOT PROVIDED. SECTION D6A - IMPLANT DATE: EXACT DATE UNKNOWN, IMPLANT DATES WERE BETWEEN JANUARY AND JULY 2023. SECTION D6B: IF EXPLANTED; GIVE DATE: NOT APPLICABLE, AS THE LENSES REMAIN IMPLANTED. SECTION E1 - TELEPHONE NUMBER: +43 40400079110. SECTION H3 - THE DEVICES WERE NOT RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBERS WERE NOT PROVIDED. SECTION H6 - HEALTH EFFECT - CLINICAL CODE: 4581: NO CODE AVAILABLE (DEVICE DISLOCATION) CITATION: VICTOR DANZINGER, MD; DANIEL SCHARTMÜLLER, MD; MARCUS LISY, MD; MARKUS SCHRANZ, MD;CLAUDETTE ABELA-FORMANEK, MD; RUPERT MENAPACE, MD; CHRISTINA LEYDOLT, MD; JOURNAL OF REFRACTIVE SURGERY VOL. 41, NO. 4, 2025; PP E382-E390 COPYRIGHT © SLACK INCORPORATED ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: PROSPECTIVE FELLOW-EYE COMPARISON OF A SPHERICAL MONOFOCAL AND AN ENHANCED MONOFOCAL INTRAOCULAR LENS IN INTERMEDIATE AND NEAR VISION. REVIEW COMPLETION DATE: 05/06/2026. RAPID RESPONSE TEAM COMMENTS: A PROSPECTIVE, SINGLE-CENTER, FELLOW-EYE COMPARATIVE STUDY WAS DONE TO COMPARE MONOCULAR VISUAL PERFORMANCE OF ASPHERICAL AND AN ENHANCED MONOFOCAL INTRAOCULAR LENS (IOL) AFTER COMBINED IMPLANTATION. A TOTAL OF 100 EYES OF 50 PATIENTS WERE ENROLLED, WITH 45 PATIENTS (90 EYES) COMPLETING FOLLOW-UP AT 2.30 ± 0.66 MONTHS WHO UNDERWENT BILATERAL CATARACT SURGERY AND IMPLANTATION OF THE SPHERICAL SENSAR AAB00 IOL (JOHNSON & JOHNSON VISION) IN THE DOMINANT EYE AND THE ENHANCED MONOFOCAL EYHANCE ICB00 IOL (JOHNSON & JOHNSON VISION) IN THE NON-DOMINANT EYE. IT WAS REPORTED THAT TOTAL OCULAR HIGHER ORDER ABERRATION HOA AT 5 MM, OCULAR SPHERICAL ABERRATION (SA) Z(4,0), AND INTERNAL SA Z(4,0) AT BOTH 5 AND 3 MM ALL SHOWED SIGNIFICANT DIFFERENCES AND WERE MORE NEGATIVE IN THE ENHANCED MONOFOCAL ICB00 GROUP. MOREOVER, BOTH GROUPS EXHIBITED LOW VALUES OF IOL TILT (SENSAR AAB00 IOL: 4.86 ± 1.52° [RANGE: 1.60 TO 8.00°]; EYHANCE ICB00 IOL: 5.13 ± 1.50° [RANGE: 1.40 TO 8.80°]) AND IOL DECENTRATION (SENSAR AAB00 IOL: 0.20 ± 0.11 MM [RANGE: 0.01 TO 0.42 MM]; EYHANCE ICB00 IOL: 0.17 ± 0.09 MM [RANGE: 0.03 TO 0.47 MM]). ADDITIONALLY, PATIENT-REPORTED FUNCTIONAL LIMITATIONS WERE CAPTURED USING THE VF-7 QUESTIONNAIRE. DIFFICULTY DRIVING AT NIGHT WAS REPORTED IN 11% (5/44) OF PATIENTS AS MILD AND IN 2% (1/44) AS SEVERE. MILD DIFFICULTY WAS ALSO REPORTED IN 2% (1/44) OF PATIENTS EACH FOR WATCHING TELEVISION, SEEING STEPS OR CURBS, AND READING SIGNS. CITATION: VICTOR DANZINGER, MD; DANIEL SCHARTMÜLLER, MD; MARCUS LISY, MD; MARKUS SCHRANZ, MD; CLAUDETTE ABELA-FORMANEK, MD; RUPERT MENAPACE, MD; CHRISTINA LEYDOLT, MD; JOURNAL OF REFRACTIVE SURGERY VOL. 41, NO. 4, 2025; PP E382-E390 COPYRIGHT © SLACK INCORPORATED SUBMITTED: JANUARY 7, 2025. ACCEPTED: MARCH 7, 2025. PUBLISHED ONLINE: APRIL 1, 2025. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. THIS REPORT IS FOR THE AAB00 LENSES. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ICB00 LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380239 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AAB00

    Patients

    Seq Age Sex Outcome Treatment
    1