Catalog Number 8065752914 |
Device Problems
Loose or Intermittent Connection (1371); Failure to Calibrate (2440); Excessive Heating (4030); Priming Problem (4040)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/11/2024 |
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 an ophthalmic handpiece became hot during longitudinal testing, during procedure setup the tuning and calibrating the handpiece was unsuccessful.Details of procedure and patient harm was not reported.The issue was observed during testing of the handpiece.
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Event Description
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A customer reported that an ophthalmic handpiece became hot during longitudinal testing, during procedure setup the tuning and calibrating the handpiece was unsuccessful.Details of procedure and patient harm was not reported.The issue was observed during testing of the handpiece.Upon further review, it was confirmed that loose tip was the only valid reported event stated by the customer.
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Manufacturer Narrative
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Corrected information has updated in b.2, b.5 and h.11.Initial report was incorrectly submitted in initial reporting, after further review this file doesn't meet reporting criteria.Further reports will not be submitted under reference number: (b)(4) the manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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