Additional code was updated per ir results, as a result the following fields have been updated: section d10: device available for evaluation ¿ yes, returned to manufacturer on 1/20/2020.Section h3: device returned to manufacturer ¿ yes.Section h6: device code: 1069.Device evaluation: the product was received dry in a little jar.The product was disinfected according to procedure wv0491.The product is inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.The optic body is torn, no other anomalies were identified.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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