BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 24654704 · Received March 20, 2026

    Report

    Report Number
    3012236936-2026-000062
    Event Type
    Injury
    Date Received
    March 20, 2026
    Report Date
    March 20, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: UPON REVIEW, THE MODIFIED YAMANE (MY) TECHNIQUE IS ASSESSED AS AN OFF-LABEL PROCEDURE FOR THE THREE PIECE SENSAR AR40E INTRAOCULAR LENS (IOL). THEREFORE, IOL DECENTRATION ISSUE MENTIONED IN THE ARTICLE (REFERENCE TABLE 3) DOES NOT APPLY TO THE SENSAR LENS. IN ADDITION, INCREASED INTRAOCULAR PRESSURE EVENT WAS ASSESSED AS NOT REPORTABLE FOR THE JOHNSON AND JOHNSON DEVICE. 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. GENERAL DEMOGRAPHICS DATA WAS PROVIDED FOR SECTIONS A2 AND A3B AS INDICATED BELOW. SECTION A2, AGE (YEAR): 69 +/- 24 FOR GROUP MY (N=17) AND 68 +/- 29 FOR GROUP MDF (N=12), P-VALUE = 0.31. SECTION A3B: GENDER (F/M): 7/10 FOR GROUP MY (N=17) AND 4/8 FOR GROUP MDF (N=12), P-VALUE = 0.46 SECTION B3: DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JUNE 11, 2025. SECTION D4: CATALOG#: A COMPLETE NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL#: UNKNOWN/ NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: UNKNOWN/ NOT PROVIDED. SECTION D6B: EXPLANT DATE: N/A - LENS REMAINS IMPLANTED. SECTION H3: THE INTRAOCULAR LENS WAS NOT RETURNED FOR ANALYSIS (THE DEVICE REMAINS IMPLANTED). 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. CITATION: M. ICOZ, E. ERKAN, RESULTS OF TWO DIFFERENT TECHNIQUES FOR SUBLUXATED ONE-PIECE INTRAOCULAR LENSES: MODIFIED YAMANE TECHNIQUE VERSUS MODIFIED DOUBLE-FLANGE TECHNIQUE. EUROPEAN JOURNAL OF OPHTHALMOLOGY, 2025. DOI: 10.1177/11206721251353661. 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: RESULTS OF TWO DIFFERENT TECHNIQUES FOR SUBLUXATED ONE-PIECE INTRAOCULAR LENSES: MODIFIED YAMANE TECHNIQUE VERSUS MODIFIED DOUBLE-FLANGE TECHNIQUE. A RETROSPECTIVE STUDY WAS DONE TO COMPARE THE MODIFIED YAMANE (MY) TECHNIQUE WITH THE MODIFIED DOUBLE-FLANGE (MDF) TECHNIQUE IN MANAGING SUBLUXATED SINGLE-PIECE FOLDABLE INTRAOCULAR LENSES (IOLS). A TOTAL OF 29 EYES OF 29 PATIENTS REQUIRED SURGICAL INTERVENTION DUE TO THE SUBLUXATION OF A SINGLE-PIECE FOLDABLE IOL (N=17 EYES IN THE MY GROUP AND N=12 EYES IN THE MDF GROUP). IN THE MY GROUP, A THREE-PIECE IOL (SENSAR AR40E, AMO) WAS USED AND LOADED INTO A CARTRIDGE AND INJECTOR SYSTEM AND INSERTED INTO THE ANTERIOR CHAMBER. POSTOPERATIVE COMPLICATIONS REPORTED IN THE MY GROUP POTENTIAL RELATED TO INSERTER SYSTEMS INCLUDE PSEUDOPHAKIC BULLOUS KERATOPATHY (N=1 EYE) (NO INTERVENTIONS DONE) NOTE: THIS IS FILE 1 OF 3 AS A TOTAL OF 3 PATIENTS WERE MENTIONED WITH CYSTOID MACULA EDEMA, REFERENCE TABLE 3 OF THE ARTICLE. TWO ADDITIONAL REPORTS ARE BEING FILED. A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708261 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention