Description of Event or Problem · 0
THIS LETTER IS TO INFORM YOU THAT ALCON HAS RECEIVED INFORMATION THAT REASONABLY SUGGESTS THAT AN ADVERSE EVENT HAS OCCURRED ASSOCIATED WITH PRODUCTS NOT MANUFACTURED BY ALCON. ON (B)(6) 2013, AN EYE CARE PROVIDER REPORTED THAT A PATIENT EXPERIENCED AN ADVERSE EVENT WITH STELLA BRAND CONTACT LENSES. WE ARE UNABLE TO DETERMINE THE MANUFACTURER. THE PRODUCT IS LABELED AS "DISTRIBUTED BY JDH PREMTER SOLUTION INC." THE PATIENT PRESENTED WITH 'SEVERE CORNEAL SCARRING' DIRECTLY RELATED TO A BEAUTY SHOP PURCHASE OF CONTACT LENSES, AND THAT SHE 'MUST HAVE HAD A NASTY INFECTION AND DID NOT GET TREATED'. NO FURTHER RELEVANT MEDICAL INFORMATION WAS PROVIDED, AND NO PATIENT DETAILS WERE PROVIDED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).