Model Number 590106AN |
Device Problems
Suction Problem (2170); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/02/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4): the patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor's technique in applying the suction ring to the cornea, doctor's technique in squeezing the pi cllip to secure the suction ring to the pi cone and patient anatomy affecting the sinterface between the patient's cornea and the suction ring.All pertinent information available to abbott medical optics has been submitted.
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Event Description
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Account reported that with 4 seconds left on the treatment a galvo error generated.After acknowledging the error a suction loss during laser firing occurred.The surgeon reapplied suction, removed the hinge setting and retreated from the beginning.There is no patient injury reported and the case was completed.Treatment was a success.
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Manufacturer Narrative
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(b)(4).In initial report the common device name was reported as femtosecond laser incorrectly.The correct common device name for this report is patient interface.
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Search Alerts/Recalls
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