BIOFINITY TORIC (COMFILCON A)

Additional Manufacturer Narrative

NO DEVICE SAMPLE WAS RETURNED FOR ANALYSIS; HOWEVER, A LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE EVENT. MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO-ISSUES OR NON-CONFORMANCES. BASED ON THE AVAILABLE INFORMATION, NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT COULD NOT BE CONFIRMED. WHILE THE EVENT IS REPORTED TO HAVE OCCURRED IN THE LEFT (OS) EYE ONLY, INFORMATION WAS PROVIDED FOR TWO DEVICES, AND IT IS NOT CLEAR WHICH DEVICE IS INVOLVED IN THE EVENT. AS SUCH, BOTH DEVICES ARE BEING REPORTED AS POTENTIALLY INVOLVED, PLEASE REFER TO LINKED MANUFACTURER REPORT 9614392-2026-00025 FOR ASSOCIATED INCIDENT REPORT.

Description of Event or Problem

THIS INCIDENT WAS REPORTED BY THE CONTACT LENS DISTRIBUTOR, (B)(4) LOCATED IN THE NETHERLANDS TO THE MANUFACTURER AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. HOWEVER, (B)(4) HAD INITIALLY RECEIVED THE REPORT FROM A SUBSIDIARY DISTRIBUTOR, LOCATED IN GERMANY REGARDING AN INCIDENT THAT OCCURRED IN GERMANY AS RELAYED BY THE END USER. IT WAS ALLEGED THAT THE PATIENT HAS EXPERIENCED AN UNSPECIFIED EYE INFECTION WITH SYMPTOMS OF INFLAMMATION AND DULL PAIN IN THE LEFT (OS) EYE. IT IS ALSO REPORTED THAT THE CONTACT LENS HAD TORN AND THE USER REQUIRED ASSISTED LENS REMOVAL. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE ALLEGATION OF UNSPECIFIED EYE INFECTION WITH LACK OF MEDICAL INFORMATION, UNKNOWN THE TYPE, NATURE OR SEVERITY OF THE REPORTED INFECTION AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR THE NECESSITY OF MEDICAL INTERVENTION OR MEDICATION TO PREVENT OR PRECLUDE SUCH OCCURRENCE ASSOCIATED WITH SOME OCULAR INFECTION EVENTS. SHOULD FURTHER RELEVANT MEDICAL INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL PROVIDE THOSE DETAILS IN THE APPLICABLE FOLLOW-UP REPORT. WHILE THE EVENT IS REPORTED TO HAVE OCCURRED IN THE LEFT (OS) EYE ONLY, INFORMATION WAS PROVIDED FOR TWO DEVICES, AND IT IS NOT CLEAR WHICH DEVICE IS INVOLVED IN THE EVENT. AS SUCH, BOTH DEVICES ARE BEING REPORTED AS POTENTIALLY INVOLVED, PLEASE REFER TO LINKED MANUFACTURER REPORT 9614392-2026-00025 FOR ASSOCIATED DEVICE INCIDENT REPORT.