Model Number SN6AT3 |
Device Problem
Unintended Movement (3026)
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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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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A facility representative reported an intraocular lens, with a description of "lens flipped in cartridge".Additional information has been requested.
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Event Description
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Additional information was provided indicating that the iol flipped while being advanced in the cartridge.There was no patient contact.
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Manufacturer Narrative
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Additional information was provided in b.5 and h.10.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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