Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Pain (1994); Blurred Vision (2137); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A physician reported a patient experienced acute endophthalmitis after a surgical procedure.The patient presented with pain and blurred vision in the right eye.Conjunctival inflammation, aqueous cell, aqueous fibrin and hypopyon was noted.The patient received repeated treatment of intraocular antibiotics and frequent topical antibiotics and steroids.The patient's symptoms have completely resolved with good visual outcome.This is the second of two reports from this facility.
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Manufacturer Narrative
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This is a closed system.It is operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phacoemulsification (phaco) handpiece is a reusable device that must be reprocessed per the product dfu.There is no evidence that the design or performance of the system caused or contributed to this reported event of endophthalmitis.The system serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been received indicating that the surgeon does not suspect sterilization process.
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Search Alerts/Recalls
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