Catalog Number 8065750502 |
Device Problems
Device Inoperable (1663); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/29/2018 |
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 customer reported that during a cataract procedure, the ultrasound was not working and the system did not recognize the phacoemulsification handpiece.The case was completed manually.
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Manufacturer Narrative
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The company service representative examined the system and was able to confirm the reported event.The phaco controller printed circuit board (pcb) was nonconforming and was replaced.The system was then tested and met all product specifications.The system was manufactured on april 16, 2012.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming phaco controller printed circuit board (pcb).The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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