Catalog Number 8065753008 |
Device Problems
Suction Problem (2170); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
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 physician reported that during a intra ocular implantation surgery (iol) surgery in an ophthalmic operating console was presented with poor aspiration in visco mode and no flow.The patient harm was not reported.Additional information has been and none received till date.
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Manufacturer Narrative
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Corrected information has been provided in section b.5.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that during a intra ocular implantation surgery (iol) surgery in an ophthalmic operating console it was observed that there was no flow.The patient harm was not reported.Additional information has been and none received till date.
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Search Alerts/Recalls
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