BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNK TYPE)

    MDR report key: 801231 · Received January 2, 2007

    Report

    Report Number
    1313525-2007-00005
    Event Type
    Injury
    Date Received
    January 2, 2007
    Date of Event
    February 1, 2006
    Report Date
    October 30, 2006
    Manufacturer
    BAUSCH & LOMB INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSCH & LOMB IS UNABLE TO COMPLETE AN INVESTIGATION OF THIS COMPLAINT SINCE NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IN 2006, THE PT PRESENTED WITH COMPLAINTS OF PAIN, REDNESS, INCREASED TEARING, PHOTOPHOBIA OS X 10 DAYS. PT WAS SEEN BY A PHYSICIAN WHO DIAGNOSED CORNEAL ULCER OS - R/O ACANTHAMOEBA. A CORNEAL SCRAPING AND CULTURE WAS PERFORMED. ACANTHAMOEBA KERATITIS HAD BEEN DIAGNOSED A WEEK EARLIER (PHYSICIAN UNK) AND PT HAD BEEN PRESCRIBED VIGAMOX, ATROPINE AND TRIFLURIDINE. FOLLOW-UP EIGHT DAYS LATER, PT'S PAIN IMPROVED. HYPOPION SEEN, POST INFILTRATE. DIAGNOSIS OF KERATITIS OS. THREE DAYS LATER, MEDICATIONS CHANGED TO BAQUACIL, CHROHEXIDINE, AND BROLENE FOLLOWING POSITIVE CULTURE RESULTS FOR ACANTHAMOEBA. HYPOPION NEGATIVE. SUBSEQUENTLY, PT SEEN REGULARLY IN FOLLOW-UP WITH ADJUSTMENTS IN MEDICATIONS. BY A MONTH LATER, PT REPORTS LESS PAIN, VISUAL ACUITY SLIGHTLY BETTER. BY LAST DOCUMENTED VISIT 44 DAYS LATER, A DIAGNOSIS OF CORNEAL ULCER OS; ACANTHAMOEBA KERATITIS; SCAR OS. CONTINUE ON BROLENE, BAQUACIL AND HYOSCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU (UNK TYPE) MULTI-PURPOSE SOLUTION FOR SOFT CONTACT LENSES LPN BAUSCH & LOMB INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R ACUVUE SOFT CONTACT LENSES