Catalog Number 8065977763 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that during an intraocular lens (iol) implant procedure, the lens came out damaged from the cartridge.There has been at least 3 events with 1 known event date.Patient impact is unknown.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Customer indicated the use of an unspecified lens.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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