Model Number SN6AT5 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Vision (2139); Discomfort (2330)
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Event Date 08/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: the product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.(b)(4).
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Event Description
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A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient reported discomfort and vision loss.The lens was removed in a secondary procedure.No further information is expected.
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Manufacturer Narrative
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Product evaluation: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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