Catalog Number 8065751763 |
Device Problems
Display or Visual Feedback Problem (1184); Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Swelling (2091); Capsular Bag Tear (2639)
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Event Date 04/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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A nurse reported during a cataract extraction procedure with intraocular lens implant procedure in the left eye a system message was displayed and the foot switch did not work.The staff attempted several tries of reconnecting the cable and turning the machine off and on with no resolution to the issue.The female patient experienced a posterior capsule tear.The eye swelled making it impossible to insert the intraocular lens due to the 2 hour delay in the procedure.Additional information has been requested.
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Manufacturer Narrative
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The footswitch serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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