BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR EYES CLR SOOTHING DROPS

    MDR report key: 151352 · Received February 23, 1998

    Report

    Report Number
    1528738-1998-00010
    Event Type
    Injury
    Date Received
    February 23, 1998
    Date of Event
    December 27, 1997
    Report Date
    January 26, 1998
    Manufacturer
    ROSS PRODUCTS DIV/ ABBOTT MFG., INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT CONTAINS A SORBIC ACID (0.25%) AND EDETATE DISODIUM (0.1%) PRESERVATIVE SYS. THE SHELF LIFE OF THE PRODUCT IS 15 MOS. BATCH RECORD REVIEW. CO HAS MADE 5 ATTEMPTS TO OBTAIN THE NAME AND PHONE NUMBER OF THE PT AND A SAMPLE OF THE SUSPECT PRODUCT BETWEEN 01/26/98 AND 03/30/98. H7. ROSS HAS NOT INITIATED A REMEDIAL ACTION REGARDING THIS PROBLEM AND DOES NOT ANTICIPATE INITIATING A REMEDIAL ACTION IN THE FUTURE.

    Description of Event or Problem · 1

    CO HAS NO FURTHER INFO DESCRIBING THE INCIDENT OR RELEVANT EVENTS OCCURRING PRIOR TO OR SUBSEQUENT TO THE ACTUAL INCIDENT. CO HAS NO FURTHER EVAL OF THE INCIDENT BY ANY HEALTHCARE PROFESSIONAL INVOLVED IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR EYES CLR SOOTHING DROPS 86 LPN CLEANING AND WETTING AGENTS LPN ROSS PRODUCTS DIV/ ABBOTT MFG., INC. 6532-01 28-963-AW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NONE REPORTED.