FOCUS DAILIES

Additional Manufacturer Narrative

H.3., H.6.: THE COMPLAINT SAMPLE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4) H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

THIS COMPLAINT IS IN REFERENCE TO THE ALCON PRODUCT FOCUS DAILIES, ALCON ATLANTA DAILIES. A CONSUMER SUBMITTED A REPORT STATING THAT LENS WAS TORN WHILE IN THE RIGHT EYE AND THE EYE BECAME RED. THE CONSUMER SOUGHT MEDICAL ATTENTION AND WAS DIAGNOSED WITH MINOR EYE SCRATCHES, AND UNSPECIFIED EYE DROPS WERE PRESCRIBED. UPON FOLLOW-UP WITH THE CONSUMER, IT WAS REPORTED THAT THE CONSUMER REVISITED THE DOCTOR AND WAS PRESCRIBED PRANOPROFEN NON-STEROIDAL ANTI-INFLAMMATORY EYE DROPS FOR SYMPTOM RELIEF. AT THE TIME OF THIS REPORT, THE CONSUMER¿S SYMPTOMS ARE RESOLVED. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED AT THE TIME OF THIS REPORT.