MYDAY TORIC (STENFILCON 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. 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 2640128-2026-00013 FOR ASSOCIATED INCIDENT REPORT.

Description of Event or Problem

THIS INCIDENT WAS COMMUNICATED TO THE MANUFACTURER BY THE DISTRIBUTOR, (B)(4), LOCATED IN THE NETHERLANDS. HOWEVER, (B)(4) HAD INITIALLY RECEIVED THE REPORT FROM A SUBSIDIARY DISTRIBUTOR, (B)(4), LOCATED IN GERMANY, REGARDING AN INCIDENT THAT OCCURRED IN GERMANY AS RELAYED BY THE END USER. IT WAS ALLEGED THAT THE PATIENT HAS EXPERIENCED UNSPECIFIED EYE INFECTIONS ON MULTIPLE OCCASIONS, WHICH THEY BELIEVE IS RELATED TO CONTACT LENS USE. 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 INFECTIONS WITH THE LACK OF MEDICAL INFORMATION, INCLUDING THE TYPE, NATURE, OR SEVERITY OF THE REPORTED INFECTIONS 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 INFECTIONS. SHOULD FURTHER RELEVANT MEDICAL INFORMATION BE MADE AVAILABLE, THE MANUFACTURER WILL PROVIDE THESE DETAILS IN THE APPLICABLE FOLLOW-UP REPORT. 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 2640128-2026-00013 FOR ASSOCIATED INCIDENT REPORT.