Catalog Number 8065751077 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2023 |
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 the interface of the phacoemulsification suction tube and the phacoemulsification handpiece were not tightly connected during the anterior section the cataract and vitrectomy combination surgery.The product was replaced, and surgery was completed.There was no patient harm.
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Event Description
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As a result of an internal review of the file, it was determined that the information provided for this event having loose connecter issue due this the interface of the phacoemulsification suction tube and the phacoemulsification handpiece were not tightly connected during surgery, does not represent a reportable malfunction.
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Manufacturer Narrative
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As a result of an internal review of the file, it was determined that the information provided for this event does not represent a reportable device malfunction.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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