Model Number 1MTEC30 |
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: all events of cartridge tip cracked or damaged were related to tip deformed.Products have not been returned.Lot numbers of suspect products.Cd04808 quantity 7.Unknown quantity 2.Cd07065.Seven investigations out of the 10 were completed and they concluded the products met manufacturing release criteria and no product deficiency was identified.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 10 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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Additional information: there were 2 investigations completed during this period.Both products were returned and all the tip was observed deformed.No manufacturing issues were identified.
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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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