AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN, INFORMATION NOT PROVIDED. BEST ESTIMATE IS BETWEEN (B)(6) 2019. (B)(4). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO COMPLAINT WAS REPORTED IN THE PREVIOUS 12 MONTHS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
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Patient 1
CONSUMER REPORTED THAT SHE PURCHASED BLINK AND CLEAN LENS DROPS AROUND (B)(6) BUT UPON USING THE DROPS SHE EXPERIENCED IRRITATION, TINGLING AND BUMPS. SHE STOPPED USING THE DROPS AND THE SYMPTOMS ABATED. HER DOCTOR PRESCRIBED ANTIBIOTICS AND BLINK LUBRICATING DROPS FOR HER DRY EYE AND TO PROVIDE IMMEDIATE COMFORT. SHE TRIED THE BLINK AND CLEAN LENS DROPS AGAIN YESTERDAY ((B)(6) 2020) AND EXPERIENCED THE SAME THING PLUS IRRITATION ON THE EYE LID AND THE SKIN AROUND THE EYE. HER EYES FEEL BETTER BUT ARE STILL TENDER. THRU ADDITIONAL FOLLOW-UP THE CONSUMER REITERATED THAT HER EYES FEEL BETTER ALTHOUGH THERE IS STILL DISCOMFORT. ADDITIONALLY, SHE REPORTED THAT HER EYES ARE SENSITIVE TO ?SCREENS? AND LIGHT. NO FURTHER INFORMATION WAS PROVIDED.