Model Number SN6AT3 |
Device Problem
Scratched Material (3020)
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Patient Problem
Optical Nerve Damage (1986)
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Event Date 06/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: 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 nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, a scratch was found on the optic.The iol was exchanged during the initial procedure with the same model and power iol.The patient's eye was well.
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Manufacturer Narrative
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The used cartridge was returned.Inadequate viscoelastic is observed in the cartridge.The cartridge has evidence it was placed in a handpiece.No damage observed.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.The root cause is most likely related to a failure to follow the directions for use (dfu).The dfu instructs to fill the cartridge with viscoelastic before loading the lens.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Product evaluation: the product was returned for analysis and the reported damage was observed.Additional observations were as follows: iol returned in three pieces adhered to adhesive tape.A significant amount of solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned.The optic has two parallel torn/split-cuts, dividing it into three segments.The optic is also cracked/fractured and scratched/marked-rejectable with loose fibers & particulate.The product investigation could not identify a root cause for the reported complaint ¿iol optic scratched¿.The product was subject to handling and the reported damage was highlighted post implantation.The returned iol shows evidence of handling by the customer due to the presence of solution dried on the returned segments.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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