Description of Event or Problem · 0
FEW DAYS AGO, I BOUGHT 5 PAIRS OF KOREAN BRAND CONTACT LENSES WHICH NAMED APRILEYE AT THEIR OFFICIAL WEBSITE. (HTTPS://WWW.APRILEYE.COM/) BEFORE I GOT MY DELIVERY, I THOUGHT IT WAS VERY GUARANTEED BECAUSE OF THE I-CODI MANUFACTURER IN SOUTH KOREA. HOWEVER, WHEN I RECEIVED THE PARCEL AND PUT THE LENSES ON, MY EYES HURT AND BECAME VERY RED. AND NOW MY EYES STILL SORE. BECAUSE OF IT, I DID SOME RESEARCH ON THIS PRODUCT AND THE BRAND, I SERIOUSLY DOUBT THAT THIS PRODUCT IS PIRATED. AS FAR AS I KNOW, THE CONTACT LENS I PURCHASED IS A SOFT HYDROPHILIC CONTACT LENS, WHICH BELONGS TO THE CLASS II MEDICAL DEVICE PUBLISHED BY THE FDA. AFTER CONFIRMATION, IT WAS FOUND THAT THIS PRODUCT DOES NOT MEET THE REQUIREMENTS OF FDA REGULATIONS. WHAT I FOUND IS: 1. THE 510(K) NUMBER WHICH IS K43431 OF I-CODI THAT THE REPLACEMENT CYCLE OF THE COLOR BOX IS CONTRADICTORY WITH THE LABEL DESCRIPTION. THE REPLACEMENT CYCLE OF THE COLOR BOX TRADEMARK NOTE IS 6 MONTHS, AND THE LABEL STICKERS ARE THROWN OUT IN THE YEAR. 2. THE INSTRUCTIONS ARE TOO SIMPLE. THERE ARE NO INDICATIONS, NO WEARING, NO REQUIREMENTS FOR NURSING METHODS, AND NO OPTICIAN GUIDELINES. 3. SOME PRODUCTS HAVE UDI ON THE LABEL, SOME ARE NOT. ALSO, I CAN'T SCAN ANY INFORMATION FROM THE CODE. 4. THE PRODUCT NAME IS DIFFERENT FROM THAT PUBLISHED ON THE FDA WEBSITE; I SERIOUSLY SUSPECT THAT THIS PRODUCT IS A FAKE PRODUCT OF I-CODI. PLEASE CHECK AND DISPOSE OF IT. THANK YOU FOR YOU PATIENT. HOPE TO GET THE FEEDBACK ASAP. KINDLY REGARDS. REFERENCE REPORTS: MW5144535, MW5144536, MW5144537 AND MW5144538.