[189000205]
Age/date of birth: unknown, information not provided. Date of event: date of event: exact date unknown, information not provided. Best estimate is during (b)(6) 2019. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[189000206]
It was initially reported a consumer used oxysept 1step for a few days and found mold on his lens. The lenses were worn, and afterwards the consumer felt itchy and had more eye discharge than usual. The consumer sought medical attention and was prescribed genderon ophthalmic solution and fluorone. The eye specialist asked to see him again for further examination. The consumer wears extended wear contact lenses. Additional information and clarification were provided, the consumer found there was a dark substance in the bottom of the lens case (the lens case was fresh from the oxysept 1step solution), and suspected it was mold. The contact lenses looked normal, so he wore the lenses regardless, afterwards, he experienced discomfort, irritation, itchiness and eye discharge. He emphasized that he used the solution and the tablet correctly according to the instructions for use (ifu). Through follow-up the patient responded to the question; how long did the lenses soak in neutralized solution before being worn; the consumer could not recall how many days it was after lenses were placed in the solution. The ifu notes that? If you do not intend to wear your lenses immediately after disinfection/neutralization, you may store them in the unopened oxysept cup. Disinfect and neutralize with fresh solution once a week before applying the lenses to your eyes?. The next time the consumer used the lenses (2? 3 days later), the consumer found the dark substance had increased in size, and some was on the lenses, therefore he did not continue to use the lenses. The consumer has not yet gone to get his eyes rechecked. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5