Consumer has been using addipak single use 5 ml sterile 0.9% nacl with their scleral hard contact lenses, for a few years without issue.The consumers doctor recommended the use of this product in an off-label manner.The consumer purchased 2 new boxes of addipak in late (b)(6) 2021 and began use of the new boxes in (b)(6) 2021.Upon the first use of the addipak saline from the new boxes/lot the consumer stated they noted an immediate burning and eye irritant, like a chemical reaction.Complaint # (b)(4).
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