Catalog Number 8065571000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932)
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Event Date 07/29/2020 |
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 healthcare professional reported that a patient experienced endophthalmitis postoperatively.The patient was hospitalized and was started on ongoing antibiotic and corticosteroid treatment; the patient has since experienced a gradual decrease in inflammation and corneal edema.A vitrectomy was performed for vitreous sampling.All the culture samples came back negative.The facility has cancelled all ophthalmic procedures since (b)(6) 2020.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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There was no sample returned for evaluation.The chemical lab tested a reference sample on ph and osmo and all tests are conform the specifications for the tested parameters.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.As no manufacturing related issues were identified, reference sample is conform the specifications for the tested parameters and no sample is available, a conclusive root cause could not be determined.All batches are released according to the required specifications.As no product is returned and/or insufficient product data is available, the complaint could not be verified and therefore no corrective and preventive action (capa) 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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