LIFECORE BIOMEDICAL, LLC DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC
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Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Conjunctivitis (1784); Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Blurred Vision (2137); Fibrosis (3167); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/08/2023 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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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.
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Manufacturer Narrative
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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.No product returned/insufficient information: as no product is returned, the complaint could not be verified and therefore no is initiated.However further trending is performed.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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