(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.Note: the device was manufactured at the (b)(4) site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Corrected data: per follow-up communication, the replacement lens details are zcu225 20.0 diopter which was reported as a model zct225 20.0 diopter in the initial report.Additional information: additional information noted a capsular tension ring (ctr) was implanted at the same time as the replacement lens, a model 275us1g00 sn_(b)(6).Section d10: device available for evaluation ¿ yes, returned to manufacturer on 8/21/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the complaint lens received in an unknown solution with a swab inside a test tube placed inside a specimen cup.Additional documentation was received as well.Visual inspection under magnification revealed that the lens was received cut (but not separated), which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation via visual inspection could be performed.Dimensional inspection was performed (only on both haptics due to the cut on the optic body), and all measurements were within specifications.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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