Model Number SA6AT5 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Code Available (3191)
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Event Date 11/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information was requested and received.(b)(4).
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Event Description
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A facility representative reported that one month following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens model and power.The reason given was wrong power for the patient.The representative reported there was no enlarged incision or sutures required.
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Manufacturer Narrative
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Product evaluation: the lens was returned in a piece of surgical gauze.Solution is dried on the lens.The lens was cut in half.The optic has a small split coming from the gusset area.The optic is also split for the optic edge towards the center of the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.The lens was returned cut in half.A power/resolution test could not be performed due to the lens being cut in half.Product history records were reviewed and the documentation indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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