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 04/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.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 facility representative reported that during an intraocular lens (iol) implant procedure, the haptic of the iol broke when delivered through the cartridge.The procedure was completed.Additional information has been requested.
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Manufacturer Narrative
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Evaluation summary: the product was returned for analysis.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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Additional information was provided, that in the surgeon's opinion, handling caused or contributed to the event.There was no harm to the patient.
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Manufacturer Narrative
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Product evaluation: the cartridge was not returned for evaluation.Only the qualified lens was returned.Blood and solution is dried on the lens.The reported broken haptic was observed.The root cause for the reported haptic damage could not be determined.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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