Additional information provided in d.4., h.3., h.6., and h.10.The company iii (d) cartridge was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Associated iol and viscoelastic were not provided.It is unknown if qualified products were used.A non-company handpiece was indicated, which is not qualified for use with company cartridges.The product investigation could not identify a root cause.The company iii (d) cartridge was not returned for evaluation.Information was provided that a non-qualified handpiece was used.The use of non-qualified combinations may result in delivery issues and/or damage.It is unknown if a qualified lens model/diopter and viscoelastic were used.No determination can be made without physical evaluation of the complaint sample.The manufacturer internal reference number is: (b)(4).
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