Model Number CCWTT6 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, lens was explanted due to toric markings being in the wrong place.Additional information has been requested and received stated that the marks for the toric are in the wrong place on the lens.There is a manufacturing error.
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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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Manufacturer Narrative
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The product was returned for analysis and the reported complaint was not observed.Toric axis marks were within specifications.Iol (intra ocular lens) returned wrapped in a wipe in a clear zip lock bag.Solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is cracked/fractured split in two and scratched/marked-rejectable.The iol met specifications when dimensionally measured for edge thickness and plan view.The axis marks are within specification.No root cause identified as the reported complaint "toric markings in wrong place" was not observed, the returned iol met specification when dimensionally measured for edge thickness and plan view, the axis marks are within specification.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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