Additional information provided in d.10., d.11., h.3., h.6., and h.10.The product was returned for analysis and the reported complaint could not be observed.The iol was returned outside the cartridge.Additional observations were as follows: iol returned in a folded position in the iol case.Solution is dried on both surfaces of the optic and haptics.Both haptics are adhered to the optic surface in a folded position.The iol met specifications when dimensionally measured for edge thickness and plan view.The used company ii b cartridge was returned.Viscoelastic was observed in the cartridge.The cartridge has evidence it was placed into a handpiece.No damage observed.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The file states the use of "provisc" as viscoelastic, which is not qualified to be used with the associated products combination.The reported complaint was not observed as the iol was returned outside the cartridge.However, based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the surgeon states the use of non-qualified viscoelastic.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.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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The product was not returned for analysis.The file states the use of "provisc" as viscoelastic, which is not qualified to be used with the associated products combination.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow the instruction of qualified iol delivery system product combinations and alternative viscoelastic, as the complainant states the use of an unqualified combination.The use of nonqualified combinations may result in delivery issues and/or damage.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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