Model Number TABLETOP |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/27/2020 |
Event Type
malfunction
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported the system was having iop compensation issue.This occurs randomly (sometimes at the beginning/ in the middle/at the end of the surgery).The issue occurs on any type of surgical procedure.The system iop compensation is activated but cuts itself off during the procedure for several seconds.The surgeon notes this issue when the eye becomes soft.Aspiration is stopped and then the iop compensation reactivates on its own.Patient hypotonia lasts about ten seconds.There have been no long term consequences for the patient.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received indicated since the last settings made by company representative, there have been no new problems and, therefore, there are no additional actions expected for this event.
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Manufacturer Narrative
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The company service representative examined the system and could not replicate the reported event of either intraocular pressure (iop) compensation or touchscreen issue.As a preventative measure, the fluidics module and touchscreen were replaced.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The system was found to have no problem; therefore, 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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