Model Number SOFTECI+19.5 |
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 11/02/2021 |
Event Type
Injury
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Event Description
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Lenstec received an email stating " surgeon noticed the lens was cracked (not sure if it was prior to insertion), removed the lens and implanted the same model/diopter with no patient 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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Search Alerts/Recalls
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