Description of Event or Problem · 0
I EXPERIENCED MULTIPLE FAILURES WITH THE REDESIGNED CLEAR CARE LENS CASE THAT POSE A SIGNIFICANT RISK OF CHEMICAL INJURY TO THE EYES. THESE ISSUES HAVE OCCURRED REPEATEDLY, AND HUNDREDS OF OTHER CONSUMERS HAVE REPORTED SIMILAR PROBLEMS ONLINE SINCE ALCON CHANGED THE DESIGN OF THE CASE AND CAP. THE PROBLEMS I PERSONALLY EXPERIENCED INCLUDE: INCOMPLETE NEUTRALIZATION AFTER 6+ HOURS, LEAVING PEROXIDE STILL ACTIVE. DRIED-OUT CONTACT LENSES DUE TO OVERFLOW CAUSED BY EXCESSIVE INTERNAL PRESSURE. THE NEW CASE APPEARS TO VENT POORLY, CAUSING PRESSURE BUILDUP, LEAKING, AND IN SOME CASES THE CAP POPPING OPEN. THESE FAILURES NEVER OCCURRED WITH PREVIOUS CLEAR CARE CASE DESIGNS. INCOMPLETE NEUTRALIZATION AND DRIED LENSES BOTH CREATE A RISK OF CORNEAL CHEMICAL BURNS, WHICH IS WHY THIS IS A SIGNIFICANT SAFETY CONCERN. NO INJURY OCCURRED BECAUSE I NOTICED THE PROBLEM BEFORE INSERTING THE LENSES, BUT THE FAILURE MODE IS HAZARDOUS AND UNPREDICTABLE. I CONTACTED ALCON DIRECTLY WITH DETAILED INFORMATION, AND THEY RESPONDED WITH A GENERIC MESSAGE DIRECTING ME TO MY EYE CARE PROVIDER AND RETAILER, WHICH DOES NOT RESOLVE A MANUFACTURER-LEVEL PRODUCT DEFECT. THE ISSUE APPEARS TIED SPECIFICALLY TO THE REDESIGNED CASE/CAP ASSEMBLY, NOT USER ERROR. BECAUSE THIS IS A RECURRING DEVICE MALFUNCTION THAT CAN CAUSE CHEMICAL EXPOSURE TO THE EYES, AND THE MANUFACTURER HAS NOT ACKNOWLEDGED OR ADDRESSED THE DESIGN DEFECT, I AM SUBMITTING THIS MEDWATCH REPORT.