Model Number 550 |
Device Problems
Material Fragmentation (1261); Loose or Intermittent Connection (1371); Material Rupture (1546); Device Operates Differently Than Expected (2913)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 09/20/2015 |
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.Additional information has been requested.(b)(4).
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Event Description
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An ophthalmic surgeon reported not expected results on patient's left eye during a laser assisted cataract surgery.Patient interface (pi) was poorly secured into the laser support which resulted in insufficient quality of the rhexis with tags, "rupture" of its integrity, incomplete fragmentation, and the incisions were not functional.It was noted that the base of the pi was loose.Additional information has been requested.This is one of three reports being filed for the same facility.This report is for the first patient.
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Manufacturer Narrative
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Evaluation summary: the system was examined and the reported event was confirmed.The bayonet was fixed properly to the system.The issue was a result of a field error.The system was found to have been functioning as intended.The system met specifications at the time of release.The root cause of the event can be attributed to a service error.
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Search Alerts/Recalls
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