Description of Event or Problem · 0
THIS PRODUCT WAS NOT MANUFACTURED OR PACKAGED BY OCUSOFT NOR DOES IT MEET THE OCUSOFT SPECIFICATIONS FOR PAD FOLDAGE, LIQUID CONTENT, OR LOCATION OF UPC CODE, LOT# OR EXPIRATION DATE! THE PRODUCT IS COUNTERFEIT AND FILED WITH SEVERAL AGENCIES FOR INVESTIGATION. THE PRODUCT IS TRADE MARKED AND FILED WITH THE US FEDERAL TRADE COMMISSION FOR FRAUD AND FOR COUNTERFEIT PRODUCT. WITH THE HOMELAND SECURITY FOR COUNTERFEIT, WITH THE FBI FOR COUNTERFEIT. EBAY AND AMAZON HAVE BEEN NOTIFIED TO STOP ALL DISTRIBUTION OF THIS PRODUCT THAT DOES NOT CONTAIN A VISIBLE UPC CODE OR LOT OR EXPIRY DATE ON THE BOTTOM SIDE OF THE CARTON. "THE LIQUID FORMULA WAS DIFFERENT". USER NOTICED THAT SHE WAS EXPERIENCING A REACTION TO THE WIPES AND THAT HER "EYELIDS WERE PEELING, NOT FLAKING BUT ACTUALLY PEELING". USER CALLED OCUSOFT CUSTOMER SERVICE AND ASKED IF OCUSOFT HAD CHANGED THE PRODUCT AND THAT THERE WERE "NO LOT NUMBER, EXPIRATION DATE OR UPC NUMBER PRINTED ON THE BOTTOM OF THE CARTON". USER AND CUSTOMER SERVICE DETERMINED THAT THE BOXES OF PRODUCT WERE COUNTERFEIT IN THAT THEY FIT THE EXACT DESCRIPTION OF PRODUCT BEING SHIPPED FROM "FAST SHIPPING" (B)(6). OWNER OF THE DISTRIBUTOR MAY BE (B)(4). THE USER WAS PROVIDED INFORMATION TO SEND THE 5 CARTONS OF PRODUCT TO OCUSOFT FOR EVALUATION (AUGUST 24, 2020). THIS COUNTERFEIT PRODUCT WAS FIRST REPORTED TO THE FDA JULY 7, 2020 BY EMAIL AND FORM 3911; TO THE FEDERAL TRADE COMMISSION ON REPORT NUMBER (B)(4) ON JULY 13, 2020; TO THE DEPARTMENT OF HOMELAND SECURITY (ICE) UNDER ALLEGATION OF COUNTERFEITING AND INTELLECTUAL PIRACY UNDER FORM ICE FORM 73-0048 SUBMISSION NUMBER (B)(4). AND TO THE FBI ON OR ABOUT THE 20TH OF JULY. PLEASE SEE ATTACHED PICTURES OF THE REACTION OF THE USER. THE PRODUCT APPEARS IDENTICAL TO OUR CURRENT PRODUCT AND BEARS OUR LOT NUMBER 3350 ON THE PACKET ONLY, BUT, IT IS NOT AN OCUSOFT PRODUCT! THE HEALTH OF THE USER, MS. (B)(6) IS MUCH IMPROVED. SHE WAS ATTENDED BY AN OPHTHALMOLOGIST WHO PRESCRIBED Z-PAC AND ERYTROMYCIN OPHTHALMIC. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).