Description of Event or Problem · 1
IF A CONTACT LENS PATIENT PRESENTS WITH SIGNS OR SYMPTOMS OF AN INFECTION AND HAS USED COMPLETE MOISTURE PLUS MULTIPURPOSE SOLUTIONS, PLEASED FIND OUT IF THEY USED ONE OF THE AFFECTED LOTS, PLEASE REPORT ANY ADVERSE REACTIONS EXPERIENCED WITH THE USE OF THIS PRODUCT BY CALLING AMO AT 1-800-347-5005 AND THE FDA'S MEDWATCH PROGRAM AT 1-800-FDA-1088, BY FAX AT 1-800-FDA-0178, BY MAIL AT MEDWATCH, HF-2, FDA, 5600 FISHERS LANE, ROCKVILLE, MD 20852-9787, OR ON THE MEDWATCH WEB SITE AT WWW.FDA.GOV/MEDWATCH. PRODUCT FROM THE RECALLED LOTS WAS DISTRIBUTED NATIONWIDE TO FOOD, DRUG AND MASS MERCHANDISER ACCOUNTS. THE RECALL DOES NOT INCLUDE 4-OUNCE OR 16-OUNCE BOTTLES, OR PROFESSIONAL SAMPLES AND PACKS PROVIDED TO EYE CARE PRACTITIONERS. THE U.S. RECALL INCLUDES APPROX 183,000 UNITS, REPRESENTING LESS THAN ONE PERCENT OF COMPLETE MOISTUREPLUS PRODUCTS IN THE U.S. ON AN ANNUAL BASIS. WHILE AMO BELIEVES THE LIKELIHOOD OF USERS EXPERIENCING AN ADVERSE REACTION IS LOW BASED UPON OUR INVESTIGATION TO DATE, WE HAVE TAKEN A CONSERVATIVE APPROACH AND ARE CONDUCTING THIS RECALL IN THE BEST INTERESTS OF OUR CUSTOMERS. THIS ACTION IS BEING CONDUCTED ON A VOLUNTARY BASIS WITH THE KNOWLEDGE OF THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). THE CO COMMENCED AN INVESTIGATION AFTER TESTING OF PRODUCTS SOLD IN FOREIGN COUNTRY DETERMINED THAT THREE DISTRIBUTED PRODUCTION LOTS WERE FOUND TO BE NON-STERILE AND CONTAMINATED WITH BACTERIA. AS A RESULT, AMO CONDUCTED A LIMITED PRODUCT WITHDRAWAL IN FOREIGN COUNTRY AND NOTIFIED APPROPRIATE GLOBAL REGULATORY AUTHORITIES, INCLUDING THE FDA. THE SUBSEQUENT INVESTIGATION TRACED THE MANUFACTURING ISSUE TO TWO OF THE FOUR PRODUCTION LINES IN ITS FOREIGN FACILITY THAT MANUFACTURED PRODUCT DURING A SPECIFIC PERIOD. THIS PRODUCT WAS SHIPPED TO THE U.S. AND TWO OTHER FOREIGN COUNTRIES, IS NOW THE SUBJECT OF THIS RECALL. AMO HAS TEMPORARILY CEASED ALL MANUFACTURING AT THE FOREIGN FACILITY AND SCHEDULED A SPECIAL CLEANING AND SANITIZATION OF THE MANUFACTURING AREA AND ALL APPLICABLE EQUIPMENT. PRODUCTS MANUFACTURED IN AMO'S FACILITY IN SPAIN, WHICH PRODUCES THE VAST MAJORITY OF AMO'S CONTACT LENS SOLUTION PRODUCTS DISTRIBUTED IN THE US AND ANOTHER FOREIGN COUNTRY, ARE NOT AFFECTED BY THIS RECALL. WE SINCERELY APPRECIATE YOUR BUSINESS AND CONTINUED TRUST IN US, AND WE APOLOGIZE FOR ANY INCONVENIENCE THIS MAY CAUSE. AMO IS COMMITTED TO DELIVERING HIGH QUALITY LENS CARE PRODUCTS AND WILL TAKE ALL NECESSARY MEASURES TO ENSURE THAT THE COMPLETE LINE OF CONTACT LENS CARE PRODUCTS REMAIN SAFE AND EFFECTIVE FOR THE DAILY DISINFECTING OF ALL SOFT CONTACT LENSES. PLEASE DO NOT HESITATE TO CONTACT ME IF I CAN ANSWER QUESTIONS OR BE OF SERVICE. PLEASE CONTACT US OR THIS PT WHO'S VERY SURE AND UPSET OVER HER DAUGHTER'S EYES. AND BLAMES THE PRODUCT. PLEASE THANK-YOU.