Model Number AH4123C |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Eye Injury (1845)
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Event Date 09/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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Microscope inspection of returned units did not find a sharp edge on the ball of any of the devices returned, as reported by the user facility.Northing found out of original device specification and conformity requirements; 'wear and tear' was observed.The devices have been well used with various knicks and dings throughout the tips, even on the shafts.
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Event Description
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Our facility had an incident today where 2 patients had a break in the posterior capsule during surgery due to a sharp edge that was observed on all 5 of our akahoshi sustainers.As a result, an unplanned anterior vitrectomy was performed, and the cases ended up being very long and complex.The sharp edge on the ball of the sustainers was clearly noticeable under the microscope.
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Manufacturer Narrative
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This report was filed in relation to report# 3019924-2023-00011 which was reported to mst to involve multiple devices and patients.This report is for the second patient impacted.
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Search Alerts/Recalls
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