Model Number CC60WF |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, there was acrylic defect in the middle of the lens.Additional information was requested, but further no information was available.
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Manufacturer Narrative
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A sample device was not returned for analysis.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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Manufacturer Narrative
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The lens was returned wrapped in surgical gauzes.Solution was dried on the lens.The optic was cut into multiple pieces, typical of insertion and removal.Qualified associated products were indicated.The root cause could not be determined for the reported complaint.The specific lens issue was not specified.Lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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