Catalog Number 8065977763 |
Device Problems
Break (1069); Split (2537)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2018 |
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 nurse reported a split cartridge during an intraocular lens (iol) implant procedure.It was reported that during the procedure, a lens was destroyed due to the fact that they could not get the lens into the cartridge.The procedure was completed with a different lens and cartridge.
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Manufacturer Narrative
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Product evaluation: the product was not returned for analysis.Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The customer indicated the use of a qualified 21.0 diopter lens, handpiece and viscoelastic.Iol product history records were reviewed and the documentation indicated the product met release criteria.The root cause may be a failure to follow the directions for use (dfu).An hcp stated that a small amount of the ovd was placed in the cartridge then a small amount was placed on the iol.The lens is then folded and inserted into the cartridge.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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