Model Number UNKNOWN |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Additional information: the event was reported for tip deformed.Lot numbers unknown and model unknown.No products returned.No investigations completed.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
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Event Description
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This report summarizes 1 malfunction events.The events were related to cartridge tip cracked or damaged.There were no patient injuries reported associated to the events.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f and g.4 date 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 (b)(4) and capa (b)(4).
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Search Alerts/Recalls
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