Model Number SN60WF |
Device Problem
Material Deformation (2976)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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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A healthcare professional reported during an intraocular lens implant procedure, the operating team had to use a backup lens since the regular lens was found out to be deformed.Additional information has been requested.
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Manufacturer Narrative
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Based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been requested and received which state there was no patient contact.
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Manufacturer Narrative
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The product was returned for analysis and the reported damage was observed.Lens returned pressed against one(1) post of the lens case base resulting in deformation of the iol.A significant amount of solution is dried on the iol.Both haptics are bent/deformed.The optic is bent/deformed and the optic edge is chipped.We are unable to determine the root cause for the reported complaint - "deformed iol".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on the iol.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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