A nurse reported that after postoperative day 14 of cataract surgery with ophthalmic handpiece, intraocular lens, phaco tip, viscoelastic device, consumable , a 68 years old female patient experienced with endophthalmitis in left eye with symptoms of eye pain, blurry vision, floater, conjunctival inflammation was <1+, aqueous cell was 3+, aqueous fibrin was present with hypopyon.Patient was treated with intravitreal tap and antibiotics, corticosteroids medications.Culture results revealed no bacterial growth.Current patient condition was unknown.This is the report of patient 3 of 4.
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Additional information is provided in sections h.6 and h.10.All batches are released according to the required specifications.A lot code would be required for review of the complaint history and the batch documentation.Adverse events are followed-up by medical safety.No product returned for evaluation.Inconclusive, no product returned: as no product returned and all initial testing results are within specification a conclusive root cause could not be determined.All batches are released according to the required specifications.None - no product returned/insufficient information: as no product is returned, the complaint could not be verified.However further trending is performed.The manufacturer internal reference number is: (b)(4).
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