Catalog Number 8065977763 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: 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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported following the implant of an intraocular lens (iol), there was a film that seemed to have separated from the cartridge.This film has adhered to the lens and is currently implanted and is not affecting the patient.Additional information was requested.
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Manufacturer Narrative
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The company iii (d) cartridge was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.The iol and viscoelastic information was not provided.It is unknown if qualified products were used.A non-company handpiece was indicated, which is not qualified for use with company cartridges.The product investigation could not identify a root cause.The company iii (d) cartridge was not returned for evaluation.Information was provided that a non-qualified handpiece was used.The use of non-qualified combinations may result in delivery issues and/or damage.It is unknown if a qualified lens model/diopter and viscoelastic were used.No determination can be made without physical evaluation of the complaint sample.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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