Additional information provided in d.4., d.11., 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.The indicated iol is qualified for use with the company iii (d) cartridge.A non-company handpiece was indicated, which is not qualified for use with company cartridges.The viscoelastic used was not provided.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.Although the root cause has not been determined, contributing factors could be: a.Viscoelastic type: the use of a non-qualified viscoelastic may result in delivery issues and/or damage.B.Viscoelastic amount: not using the appropriate amount of viscoelastic as described in the dfu may result in delivery issues and/or damage.C.Handpiece: the use of a non-qualified hand piece for the combination indicated may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).
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