BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON CONDITIONING SOLUTION

    MDR report key: 142619 · Received January 9, 1998

    Report

    Report Number
    1313525-1998-00001
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    November 7, 1997
    Report Date
    December 10, 1997
    Manufacturer
    POLYMER TECHNOLOGY CORP.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS WORN RGP CONTACT LENSES FOR 2-3 YRS AND USES THIS SOLUTION. SHE REPORTS HAVING NO PREVIOUS PROBLEMS. CATARACT SURGERY DONE ON RIGHT EYE 11/6/97 WITH INTRAOCULAR IMPLANT PLACED IN EYE. RGP LENSES WORN UP TO THE DAY PRIOR TO SURGERY. THE SOLUTION WAS USED FOR 2-3 WEEKS PRIOR TO SURGERY. AT FOLLOW UP VISIT DAY AFTER SURGERY, "CORNEAL PROBLEMS" OF THE RIGHT EYE NOTED BY DR. THE CONDITION BECAME WORSE AND 3-4 DAYS LATER, PT ALLEGEDLY WENT TO THE ER DUE TO PAIN IN RIGHT SIDE OF FACE. PT IS STILL CONTAMINATED. THE CORNEAL SPECIALIST REPORTS THE PT EXPERIENCED PAIN IMMEDIATELY FOLLOWING SURGERY AND STATES SHE IS "CONFIDENT THE PT CONTAMINATED THE SOLUTION". THE SOLUTION IN THE BOTTLE TESTED POSITIVE FOR ACANTHAMOEBA AND PENICILLIUM. THE CORNEA, LENS CASE AND LENSES TESTED NEGATIVE. THE DR STATES THE CULTURES WERE DONE AT THE HOSPS AND BECAUSE THE STRAIN OF ACANTHAMOEBA WAS UNUSUAL, THE SOLUTION WAS BEING SENT FOR FURTHER ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON CONDITIONING SOLUTION RGP CONTACT LENS CONDITIONING SOLUTION LPN POLYMER TECHNOLOGY CORP. NA GC 7074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R RGP CONTACT LENSES.