Model Number TG85ML |
Device Problem
Contamination (1120)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The healon is not an implantable device.If explanted; give date: n/a (not applicable).The healon is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that some microfibers (sometimes white, sometimes black ¿ size about 2mm) were found in the eye.These are found just after the healon is introduced into the eye, in the anterior chamber, prior to the capsular hexis.The surgeon says the healon is responsible for the issue.No additional information was provided.Two events were reported.This report represents one of the two reports.
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Manufacturer Narrative
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G9: correction: in review, of medwatch 3004750704-2019-00084 and per new information received, this event has been assessed not reportable due the fact that customer did not longer belief that particles came from a jnj product.There will be no more information provided for mfg reporting no.3004750704-2019-00084 all pertinent information available to johnson & johnson surgical vision, inc has been submitted.H3 other text : placeholder.
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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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