Model Number SOFTECHD+14.5 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.The visual inspection performed on the device determined that the lens was damaged due to being improperly handled.
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Event Description
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Lenstec received an email stating " lens was implanted and physician noted there was no haptic.Removed and replaced with same type and diopter lens using an enlarged incision without patient issues.".
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Search Alerts/Recalls
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