MYDAY TORIC (STENFILCON A)

Description of Event or Problem

THIS INCIDENT WAS REPORTED TO THE MANUFACTURER BY THE POISON CONTROL AND TOXICOVIGILANCE CENTER AT (B)(6) HOSPITAL, (B)(6) HOSPITAL OF BORDEAUX WITH REFERENCE NUMBER (B)(4), AS AN UNSPECIFIED EXPOSURE CASE RELATED TO A COOPERVISION MANUFACTURED DEVICE, WITH REQUEST FOR CHEMICAL COMPOSITION AND SAFETY DATA SHEETS. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS, AS OF THE DATE OF THIS REPORT NO FURTHER DETAILS ARE KNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE UNKNOWN NATURE, SEVERITY, OR OUTCOME OF THE INCIDENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

Additional Manufacturer Narrative

NO ROOT CAUSE COULD BE ESTABLISHED. BASED ON THE AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT HAS NOT BEEN CONFIRMED; HOWEVER, THE DEVICE CANNOT BE DEFINITIVELY EXCLUDED AS A POTENTIAL CAUSAL OR CONTRIBUTORY FACTOR.

Description of Event or Problem

THIS INCIDENT INITIALLY REPORTED ON 25 FEBRUARY 2026 AS AN UNSPECIFIED EXPOSURE EVENT REPORTED BY A HOSPITAL POISON CONTROL CENTER. ADDITIONAL EVENT DETAILS WERE RECEIVED ON 02 MARCH 2026 FROM THE POISON CONTROL CENTER. A 14 MONTH OLD CHILD CHEWED ON THE CONTACT LENS BLISTER PACKAGER AND POTENTIALLY INGESTED THE PACKAGING SOLUTION. THE CHILD DID NOT HAVE ANY SYMPTOMS FOLLOWING THE EVENT. BASED ON THIS NEW INFORMATION, THE MANUFACTURER FINDS THAT THIS DOES NOT MEET THE CRITERIA OF A SERIOUS OR REPORTABLE ADVERSE EVENT OR INCIDENT. THE CHILD DID NOT EXPERIENCE ANY NEGATIVE HEALTH IMPACT INCLUDING SIGNS, SYMPTOMS, OR CONDITIONS, AND NO MEDICAL TREATMENT WAS ADMINISTERED RELATED TO THE EVENT. NO INCIDENT OCCURRED, AND AS DOCUMENTED IN THE MANUFACTURERS RISK ASSESSMENT AND DEVICE HAZARD ANALYSIS, WERE THIS TYPE OF EVENT TO REOCCUR, IT IS UNLIKELY TO RESULT IN ANY DEATH OR SERIOUS INJURY, OR REQUIRE MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SUCH AN OUTCOME.

Additional Manufacturer Narrative

BASED ON NEWLY AVAILABLE INFORMATION, THE MANUFACTURER FINDS THAT THIS DOES NOT MEET THE CRITERIA OF A SERIOUS OR REPORTABLE ADVERSE EVENT.