Catalog Number 8065751763 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 the phacoemulsification system had handpiece loss of power issues.There was no patient harm.Procedure details were not reported.Additional information has been requested but not received.
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Manufacturer Narrative
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The service record (sr) was opened and then was subsequently cancelled, as the customer did not require an on-site assessment by the company service representative.Another sr was opened to address customer questions related to possible causes of low phacoemulsification power.Over the phone, the company technical support specialist (tss) reviewed proper surgical set-up and noted that the system was functioning as intended.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.Root cause the root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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