Model Number AU00T0 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
No Code Available (3191)
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Event Date 02/27/2020 |
Event Type
Injury
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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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An ophthalmologist reported that during a cataract surgery with an intraocular lens (iol) implant, the trailing haptic was trapped and broken inside the injector during the delivery process.The patient was left aphakic and a secondary iol surgery has been scheduled.Additional information has been requested.
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Manufacturer Narrative
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Additional information has been provided in d.10., h.3., h.6.And h.10.Evaluation summary: the device with the broken haptic was returned in the opened blister tray inside the opened carton.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has been retracted to mid-nozzle.The reported broken haptic was observed.The haptic was located ahead of the plunger in the nozzle.The distal portion was facing the end of the nozzle.The remainder of the lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported event of "haptic trapped and broken inside the injector".A broken haptic was observed in front of the plunger with the distal portion oriented toward the nozzle tip.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.A qualified viscoelastic was indicated.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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