Model Number TG85ML |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endophthalmitis (1835); No Code Available (3191)
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Event Date 06/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that the healon gv pro was used on a patient who experienced endophthalmitis.The reporter stated that they do not feel the cause was johnson and johnson related.As endophthalmitis is not self-resolving then medication is expected to have been administered.Therefore, this event has been assessed as reportable.No further information is available at this time.
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Manufacturer Narrative
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The product testing could not be performed as the product was not returned.The reported complaint could not be verified.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed three similar complaints has previously been reported on this batch, all from the same account.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Search Alerts/Recalls
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