A nurse reported that after postoperative day 14 of cataract surgery with ophthalmic handpiece, intraocular lens, phacoemulsification tip, viscoelastic device and 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 1 of 4.
|
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.All iols are terminally sterilized with 100% ethylene oxide sterilization.Company uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.Information was provided by the reporter that it was unknown what may have caused the event.The patient's vision was indicated to be improving.No further information has been provided.The investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).
|