BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR EYES CLR SOOTHING DROPS

    MDR report key: 156041 · Received March 13, 1998

    Report

    Report Number
    1528738-1998-00014
    Event Type
    Injury
    Date Received
    March 13, 1998
    Date of Event
    February 15, 1998
    Report Date
    February 16, 1998
    Manufacturer
    ROSS PRODUCTS DIVISION ABBOTT LABORATORIES
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE OF THIS REPORT: 4/27/1998. LAB COMMENTS: EVALUATION:(3/6/1998) BLUE DILATOR TIP TORN APPROX, 1CM DOWN BLUE PLASTIC CONE. LOOP OF DILATOR IS PROTRUDING FROM TEAR AND KINKED. 3/6/1998: ASSISTING WITH INITIAL OBERVATIONS: A PIECE OF THE INSERTION WIRE IS KNOTTED TO THE END OF THE LOOP OF THE DILATOR. ONE PIECE IS APPROX. 3.7CM AND ONE PIECE WHICH IS FRAYED AT THE END IS APPROX. 2CM. TUBE DOES NOT APPEAR USED. TESTING/OBSERVATIONS:(3/6/1998) REQUESTING ENGINEERING REVIEW: EXCESSIVE FORCE APPEARS TO HAVE BEEN APPLIED TO LOOP TO TEAR BLUE CONE. 3/20/1998:TWO INVERTA PEGS WITH ATTACHED DILATOR CATHETER WERE PULLED FROM RELEASED STOCK. USING TEST PROCEDURE R90.L-DTM-01 DATED 6/12/1997 INSTRON ID WAS USED TO DETERMINE FORCE REQUIRED TO TEAR BLUE CONE. SAMPLE #1 FROM STOCK DID NOT TEAR AT 70.8#. SAMPLE #2 FROM STOCK DID NOT TEAR AT 100.0#. UNABLE TO DETERMINE CAUSE OF SPLIT ON DILATOR CATHETER. REVIEW FOR PRIOR COMPLAINTS COMPLETED ON BOTH LOTS.

    Description of Event or Problem · 1

    ON 2/15/98, THE REPORTER INSTILLED DROPS IN EACH EYE AND EXPERIENCED A MILD STINGING SENSATION. AFTER 10 MINUTES ONE MORE DROP WAS INSTILLED INTO EACH EYE. THE REPORTER STATED 5 MINUTES LATER HE WAS IN AGONIZING PAIN AND COULD NOT SEE AT ALL. THE REPORTER STATED HIS EYES BECAME "BLOOD RED" AND HAD THICK SECRETIONS. THE REPORTER'S WIFE TOOK HIM TO THE EMERGENCY ROOM WHERE HIS EYES WERE FLUSHED AND WAS GIVEN A BLACK LIGHT EXAM. THE PHYSICIAN STATED THERE APPEARED TO BE NO DAMAGE TO THE CORNEA. THE PHYSICIAN NUMBED THE REPORTER'S EYES AND PRESCRIBED ANTIBIOTIC DROPS FOR HIS EYES. THE REPORTER STATED HE WAS UNABLE TO WORK AND HAD EXTREME LIGHT SENSITIVITY. ON 2/16/98, THE REPORTER STATED SOME VISION HAD RETURNED, BUT WAS STILL BLURRY. ON 2/17/98, THE REPORTER STATED THE BURNING SENSATION WAS GONE AND HIS VISION HAD IMPROVED, BUT HE WAS STILL SENSITIVE TO LIGHT. FOLLOWING A VISIT TO AN OPTOMETRIST THAT DAY, THE REPORTER WAS TOLD HE HAD SCRATCHES ON BOTH CORNEAS. THE OPTOMETRIST SAID IT HAD BEEN TOO LONG SINCE THE CAUSITIVE EVENT TO DETERMINE THE CAUSE OF THE SCRATCHES. ON PT INVOLVED.

    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 DIVISION ABBOTT LABORATORIES 6532-01 31-230-AW

    Patients

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