Model Number SN6AT5 |
Device Problem
Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The 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.(b)(4).
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Event Description
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A facility representative reported that during a cataract surgery with intraocular lens (iol) implantation, a defect was found on the center of the optic.The iol was removed from the eye and replaced with a different iol to complete the procedure.Additional information has been requested.
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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.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information was provided in h.3., h.6.And h.10.Evaluation summary: the product was returned.Solution is dried on the lens.Haptic and optic damage were observed.All product and batch history records are quality reviewed prior to product release.A qualified associated product was indicated.An unspecified handpiece was indicated.It is unknown if qualified product combinations were used.Two viscoelastics were indicated, only one is qualified for the lens/cartridge combination indicated.The reported optic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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