CLARITI 1 DAY (SOMOFILCON A)

Additional Manufacturer Narrative

NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO INVESTIGATION COULD BE COMPLETED. GIVEN THE LACK OF AVAILABLE EVENT AND DEVICE DETAILS, NO ROOT CAUSE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. AS IT IS UNKNOWN IF THE INCIDENT INVOLVED IN THE RIGHT EYE (OD), LEFT EYE (OS), OR BOTH EYES (OU), AND THE PATIENT USES A DIFFERENT DEVICE/MODEL IN EACH EYE, PLEASE REFER TO LINKED MANUFACTURER REPORT 3009108089-2026-00001 FOR ASSOCIATED INCIDENT REPORT.

Description of Event or Problem

THIS EVENT WAS REPORTED TO THE MANUFACTURER BY THE PATIENT'S CONTACT LENS PRESCRIBING AND/OR RETAILING OPTICIAN AS REPORTED TO THEM BY THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED EYE INFECTION ON THREE SEPARATE OCCASIONS AND WAS TREATED WITH UNSPECIFIED EYE DROPS. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION IS UNKNOWN. WHILE DEVICE INVOLVEMENT CANNOT BE CONFIRMED, THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE INDICATION OF AN UNSPECIFIED EYE INFECTION OF UNKNOWN NATURE OR SEVERITY, WITH LACK OF MEDICAL INFORMATION REGARDING DIAGNOSIS, TREATMENT, AND OUTCOME, AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR MEDICATION OR MEDICAL INTERVENTION REQUIRED TO PREVENT OR PRECLUDE THE OCCURRENCE OF SUCH EVENT, WHICH CAN BE ASSOCIATED WITH SOME OCULAR INFECTIONS RELATED TO CONTACT LENS USE. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE. AS IT IS UNKNOWN IF THE INCIDENT INVOLVED IN THE RIGHT EYE (OD), LEFT EYE (OS), OR BOTH EYES (OU), AND THE PATIENT USES A DIFFERENT DEVICE/MODEL IN EACH EYE, PLEASE REFER TO LINKED MANUFACTURER REPORT 3009108089-2026-00001 FOR ASSOCIATED INCIDENT REPORT.