BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1620760 · Received March 1, 2010

    Report

    Report Number
    1610287-2010-00007
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 28, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVALUATION. IT IS UNKNOWN IF THE PRODUCT WAS USED ACCORDING TO LABELED INDICATIONS. BATCH RECORDS WERE REVIEWED FOR LOT 172952F AND NO DEVIATIONS WERE IDENTIFIED. CHEMISTRY AND MICROBIAL RESULTS, ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE ALSO REVIEWED AND FOUND TO BE ACCEPTABLE. LOT 172952F MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THERE ARE NO SIMILAR REPORTS FOR THIS LOT. ADDITIONAL INFORMATION WAS REQUESTED BY FAX AND MAIL ON 02/09/2010, 02/17/2010 AND 02/22/2010 AND BY PHONE ON 02/09/2010, 02/17/2010 AND 02/22/2010. A COMPLETED QUESTIONAIRE AND MEDICAL RECORDS WERE RECEIVED FROM THE DOCTOR ON 02/17/2010 AND 02/22/2010. (B) (4)

    Description of Event or Problem · 1

    ON 01/28/2010, A CONSUMER REPORTED SHE EXPERIENCED REDNESS, BURNING, IRRITATION AND BLURRED VISION AFTER ACCIDENTALLY INSTILLING THIS PRODUCT DIRECTLY INTO HER RIGHT EYE. SHE STATED SHE FLUSHED HER EYE WITH PLAIN SALINE AND CONTACTED HER DOCTOR. ON 02/17/2010, THE CONSUMER'S DOCTOR REPORTED THAT HE HAD DIAGNOSED THE PATIENT WITH 1/2 MM CENTRAL CORNEAL ULCER IN THE RIGHT EYE. HE REPORTED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS AND CONSIDERED THE EVENT TO BE MODERATE TO SEVERE. ON 02/22/2010, MEDICAL RECORDS WERE RECEIVED AND THE DOCTOR INDICATED THAT THE CONSUMER DEVELOPED A CENTRAL CORNEAL ULCER WITH INFILTRATES, SURROUNDING HAZE AND A SMALL AMOUNT OF HYPOPYON. HE ALSO STATED THAT THE PATIENT PRESENTED WITH INCREASED PAIN, SWELLING, TEARING, DECREASED VISION, RED EYES, MUSCLE SPASMS AND SUPERFICIAL PUNCTATE KERATITIS. THE PATIENT WAS SEEN AND TREATED ON (B) (6) 2010, (B) (6) 2010 AND (B) (6) 2010 WITH A LITTLE IMPROVEMENT. ON 02/17/2010, THE DOCTOR REPORTED THAT THE INJECTION AND CENTRAL INFILTRATES WERE RESOLVING WITH A LITTLE SUPERFICIAL PUNCTATE KERATITIS REMAINING. THE DIAGNOSIS WAS STILL CORNEAL ULCER AND THE PATIENT WAS SCHEDULED TO RETURN IN TWO WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 172952F

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention