THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE RESULTS OF THE CHEMICAL TESTING PERFORMED WERE CONSISTENT WITH SHELF LIFE LIMITS. BIOBURDEN TESTING SHOWS A GROWTH IDENTIFIED AS PAENIBACILLUS SP. PAENIBACILLUS AGARIVORANS (B)(4) WAS FOUND ON THE OUTSIDE OF THE BOTTLE TIP AND INSIDE OF THE CAP. THERE WAS INSUFFICIENT SAMPLE TO PERFORM COMPLETE BIOMEDICAL TESTING. THE TESTING THAT WERE PERFORMED WERE WITHIN REQUIRED SPECIFICATIONS. DOCTOR REPORTED PATIENT'S EYELID AND SKIN FLARES WITH HIGH POLLEN SEASON AND A HISTORY OF AZELASTINE EYE DROPS. THE DOCTOR CANNOT DETERMINED IF THE EVENT IS RELATED TO A SPECIFIC PRODUCT. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
D
Patient 1
CONSUMER REPORTED VISITING AN ALLERGIST FOR PAIN IN HIS RIGHT EYE. BEFORE VISITING OFFICE, THE CONSUMER SELF-TREATED WITH VANICREAM, DESONIDE CREAM, PAZEO, AND KETOTIFEN. MEDICAL INFORMATION FROM THE ALLERGIST INDICATED PATIENT HAS A HISTORY OF PERENNIAL ALLERGIES AND A HISTORY OF TREATMENT WITH AZELASTINE (ANTIHISTAMINE) EYE DROPS. THE ALLERGIST REPORTED THE PATIENT'S EYELIDS AND SKIN FLARE WITH HIGH POLLEN SEASON. OFFICE STATES THAT PATIENT WAS SEEN FOR INFLAMMATION, SWELLING AND REDNESS ON THE RIGHT EYE. DOCTOR DIAGNOSED PATIENT WITH ALLERGIC CONJUNCTIVITIS. DOCTOR INSTRUCTED PATIENT TO USE TOBRADEX FOR THREE DAYS AND DISCONTINUE CONTACT LENS WEAR. THE ALLERGIST WAS UNABLE TO DETERMINE IF THE EVENT WAS RELATED TO A SPECIFIC PRODUCT. THE CONSUMER PROVIDED FOLLOW-UP INFORMATION THAT INDICATED HIS EYE RECOVERED AFTER TOBRADEX USE. THE CONSUMER REPORTED THAT WHEN HIS EYE RECOVERED HE BEGAN WEARING HIS LENSES AGAIN AND ALSO USED THE LENS CARE PRODUCT. PATIENT REPORTED REOCCURRENCE OF SYMPTOMS AND THAT HE HAS CONTINUED TO WEAR HIS LENSES. THE CONSUMER HAS NOT RETURNED TO A HEALTH CARE PROVIDER AT THE TIME OF THIS REPORT.
N
Patient 1
A REVIEW OF THE LOT BATCH RECORD AND TESTING OF A RETAIN SAMPLE CONCLUDED THIS PRODUCT WAS FORMULATED, MANUFACTURED AND PACKAGED ACCORDING TO LOCAL AND GLOBAL SPECIFICATIONS. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.