BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACOFLEX II

    MDR report key: 7459341 · Received April 25, 2018

    Report

    Report Number
    2648035-2018-00604
    Event Type
    Injury
    Date Received
    April 25, 2018
    Report Date
    May 22, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE CUSTOMER'S REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AS NO SERIAL NUMBER WAS PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. J CATARACT REFRACT SURG 2018; 44:6¿16 © 2018 PUBLISHED BY ELSEVIER INC. ON BEHALF OF ASCRS AND ESCRS.

    Description of Event or Problem · 1

    PUBLICATION PURPOSE: TO EVALUATE CURATIVE AND PREVENTATIVE SURGICAL STRATEGIES FOR NEGATIVE DYSPHOTOPSIA. (B)(6). DESIGN: RETROSPECTIVE CASE SERIES. METHODS: PATIENTS WITH SELF-REPORTED CHRONIC NEGATIVE DYSPHOTOPSIA HAD CORRECTIVE SURGERY AS THE THERAPEUTIC GROUP. SECOND EYE SURGERY, IN CASES WITH NEGATIVE DYSPHOTOPSIA IN THE PREVIOUSLY OPERATED EYE, COMPRISED THE PREVENTATIVE GROUP. CHRONOLOGICALLY, SEVERAL SURGICAL STRATEGIES WERE USED, INCLUDING BAG-TO-BAG INTRAOCULAR LENS (IOL) EXCHANGE, REDUCING POSTERIOR CHAMBER DEPTH, PIGGYBACK SECONDARY IOL PLACEMENT, BAG-TOSULCUS IOL EXCHANGE, AND REVERSE OPTIC CAPTURE. THE PRIMARY OUTCOME MEASURE WAS IMPROVEMENT OF NEGATIVE DYSPHOTOPSIA BY 3 MONTHS POSTOPERATIVELY. RESULTS: THE THERAPEUTIC GROUP COMPRISED 40 EYES OF 37 PATIENTS; 76.6% OF CAUSATIVE IOLS WERE ACRYLIC AND 23.4% WERE SILICONE AND ALL WERE BAG-FIXATED. THERE WERE 21 EYES IN THE PREVENTATIVE GROUP OF WHICH 11 WERE SECOND EYES FROM THE THERAPEUTIC GROUP; THE REMAINING 10 DID NOT REQUIRE SURGERY FOR THE SYMPTOMATIC EYE. SUCCESSFUL OUTCOMES FOR EACH SURGICAL STRATEGY WERE AS FOLLOWS: BAG-TO-BAG IOL EXCHANGE (0/5), A REDUCTION IN POSTERIOR CHAMBER DEPTH WITH IRIS SUTURE FIXATION OF THE BAG¿HAPTIC COMPLEX (0/1), PIGGYBACK SECONDARY IOL (8/11), SECONDARY REVERSE OPTIC CAPTURE (21/22), CILIARY SULCUS POSTERIOR CHAMBER IOL EXCHANGE (7/8), AND PRIMARY REVERSE OPTIC CAPTURE (21/21). CONCLUSIONS: NEGATIVE DYSPHOTOPSIA WAS ASSOCIATED WITH ACRYLIC OR SILICONE IOLS OF EITHER SQUARE- OR ROUND-EDGE DESIGN. NEGATIVE DYSPHOTOPSIA WAS REDUCED, ELIMINATED, OR PREVENTED WHEN THE IOL OPTIC OVERLAID THE ANTERIOR CAPSULOTOMY RATHER THAN WHEN THE CAPSULE EDGE OVERLAID THE OPTIC. BAG-TO-SULCUS IOL EXCHANGE AND REVERSE OPTIC CAPTURE WERE HIGHLY SUCCESSFUL IN MANAGING OR PREVENTING NEGATIVE DYSPHOTOPSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301704 PHACOFLEX II MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. SI30NB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention