The reference (b)(4) has been allocated to this case by rayner.The event description provided states that 8 days post iol implantation the patient presented with redness of the eye.The patient was prescribed antibiotics; however, their symptoms did not resolve.The patient was then prescribed methylprednisolone and their symptoms fully resolved within 2 weeks.Every batch of iols manufactured by rayner are tested for endotoxin and bioburden.Rayner's endotoxin acceptable tolerances are derived from bs en iso 11979-08 (2017) ophthalmic implants - intraocular lenses part 8 fundamental requirements.We have set our own limits for bioburden as there is no standard that prescribes acceptable limits.Batches are only released for distribution if the endotoxin and bioburden results are within tolerance of their respective limits which makes a rayner microbiological issue for these incidents of eye redness very unlikely.The cause of the post-operative redness of the eye has not been established.There is currently insufficient information available.No lot number has been provided to rayner to date.Rayner has requested additional information from its distributor in indonesia to facilitate further investigation of the event, including whether or not the healthcare facility uses reusable surgical instruments or single use instruments.
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