BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 17456064 · Received August 3, 2023

    Report

    Report Number
    3012236936-2023-01937
    Event Type
    Injury
    Date Received
    August 3, 2023
    Report Date
    August 3, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS (B)(6) 2020. 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 E1 - PHONE NUMBER NOT PROVIDED SECTION H3-OTHER (81): THE DEVICE 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. CITATION: (B)(6).; UNILATERAL ACUTE MACULAR EDEMA WITH SEROUS MACULAR DETACHMENT AFTER BILATERAL PHACOEMULSIFICATION; COPYRIGHT © 2021 PUBLISHED BY WOLTERS KLUWER ON BEHALF OF ASCRS AND ESCRS. 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: UNILATERAL ACUTE MACULAR EDEMA WITH SEROUS MACULAR DETACHMENT AFTER BILATERAL PHACOEMULSIFICATION TWO CASE REPORTS WERE DONE TO PRESENT 2 CASES OF UNILATERAL SEROUS MACULAR DETACHMENT AND INTRARETINAL FLUID ACCUMULATION THAT OCCURRED 1 DAY AFTER OTHERWISE UNEVENTFUL BILATERAL PHACOEMULSIFICATION PROCEDURES. A 68-YEAR-OLD MAN (CASE 1) AND A 53-YEAR-OLD MAN (CASE 2) BOTH UNDERWENT BILATERAL REFRACTIVE LENS EXCHANGE WITH HYDROPHOBIC ACRYLIC INTRAOCULAR LENS IMPLANTATION. SEQUENTIAL BILATERAL PHACOEMULSIFICATION WAS DONE ON BOTH PATIENTS USING THE WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM WITH FUSION FLUIDICS (ABBOTT MEDICAL OPTICS, INC.). ON POSTOPERATIVE DAY 1, EYE EXAMINATION AND OPTICAL COHERENCE TOMOGRAPHY (OCT) ON BOTH CASES CONFIRMED SERIOUS MACULAR DETACHMENT WITH SIGNIFICANT INTRARETINAL FLUID ACCUMULATION IN THE LEFT EYE. IN CASE 1, THE SEROUS MACULAR DETACHMENT WITH INTRARETINAL FLUID ACCUMULATION WAS COMPLETELY RESOLVED ON POSTOPERATIVE DAY 3 WITH NO ADDITIONAL TREATMENT WHILE IN CASE 2, TOPICAL NEPAFENAC 0.1% THREE TIMES DAILY WAS ADDED TO TOPICAL STEROID AND ANTIBIOTIC THERAPY AND COMPLETELY RESOLVED BY POSTOPERATIVE DAY 8. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT IS FOR PATIENT # 2 REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875402 WHITESTAR SIGNATURE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention