The reference (b)(4) has been allocated to this case by rayner.The verbatim report received from the patient states "i had cataract surgery at the end of july beginning of august.For each eye i purchased a (b)(6) upgraded lens.Starting in september, my eyes were draining mucus and liquids making it difficult it drive.I did not go to so cal eye in a timely manner.But have been there 3 times, recently.They have no idea what is causing this problem".Rayner as a medical device manufacturer cannot comment on individual cases or provide medical advice directly to members of the public.The patient has been instructed to contact a medical professional.Rayner is attempting to make direct contact with the implantating healthcare facility in order to facilitate further investigation.Every rayner lens batch is subject to endotoxin and bioburden testing prior to being approved for release and it is therefore very unlikely that the reaction experienced by the patient post-operatively is related to the lens.Our endotoxin results are derived from bs en iso 11979-08 (2017) ophthalmic implants - intraocular lenses part 8 fundamental requirements.We have set our own bioburden limits internally as there is no standard that prescribes acceptable limits.
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