BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOFOCAL IOL

    MDR report key: 18909481 · Received March 14, 2024

    Report

    Report Number
    3012236936-2024-00579
    Event Type
    Injury
    Date Received
    March 14, 2024
    Report Date
    March 14, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 57.4 ± 15.1. SECTION A3: 23 FEMALE AND 28 MALE PATIENTS. SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JULY 14TH, 2022. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN APRIL 2018 AND JUNE 2020. SECTION D4: MODEL NUMBER: COMPLETE MODEL NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: CATALOG NUMBER: COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A, LENS REMAINS IMPLANTED. SECTION H3 - OTHER (81): THE IMPLANT WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE 4581: DEVICE DECENTERED OR DISLOCATED OR TILTED SUBLUXATED OR WRONG POSITION. CITATION: F. UCAR; INTRASCLERAL FIXATION OF CAPSULAR BAG AND INTRAOCULAR LENS IN CASES WITH LARGE ZONULAR DIALYSIS; INT OPHTHALMOL (2023) 43:131¿140; HTTPS://DOI.ORG/10.1007/S10792-022-02395-2 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: INTRASCLERAL FIXATION OF CAPSULAR BAG AND INTRAOCULAR LENS IN CASES WITH LARGE ZONULAR DIALYSIS: AN OBSERVATIONAL STUDY WAS DONE TO EVALUATE THE CLINICAL OUTCOMES OF SUTURELESS CAPSULAR BAG AND INTRAOCULAR LENS (IOL) FIXATION WITH FLATTENED, FLANGED INTRASCLERAL FIXATION TECHNIQUE IN PATIENTS WITH LARGE ZONULAR DIALYSIS. A TOTAL OF 55 EYES OF 51 PATIENTS WITH ZONULAR DIALYSIS GREATER THAN 180° AND WHO HAD TRAUMATIC CATARACT, SUBLUXATED CATARACT, AND PSEUDOEXFOLIATION SYNDROME (PEX) UNDERWENT FLATTENED FLANGED INTRASCLERAL CAPSULAR BAG AND IOL FIXATION. THE IOL USED IN THE STUDY WAS THE THREE-PIECE FOLDABLE IOL SENSAR AR40 (ABBOTT MEDICAL OPTICS). IT WAS REPORTED THAT ANTERIOR CAPSULAR PHIMOSIS WAS DEVELOPED IN 2 EYES, AND NEODYMIUM:YAG (ND:YAG) LASER RADIAL ANTERIOR CAPSULOTOMY WAS PERFORMED. POSTOPERATIVE MILD IOP ELEVATION WHICH RESPONDED WELL TO TOPICAL ANTI-GLAUCOMATOUS DROPS, WAS OBSERVED IN ONLY 2 EYES. ADDITIONALLY, POSTERIOR CAPSULE OPACIFICATION (PCO) WITH CLEAR VISUAL AXIS WAS DEVELOPED IN 3 EYES. A MEAN IOL TILT OF 5.7 ± 5.2 DEGREES AT POST-OP WAS ALSO REPORTED. THE INTRAOCULAR LENS (IOL) FIXATION WITH FLATTENED, FLANGED INTRASCLERAL FIXATION TECHNIQUE USED IN THE STUDY IS CONSIDERED AS OFF-LABEL USE AS PER INITIAL MEDICAL ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589602 MONOFOCAL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention