Device evaluation: the product was not returned to the manufacturing site as it was discarded by the surgery center.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Date of event: unknown, not provided, but the best estimate date is (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that a zxt150 22.0 diopter lens was implanted in the patient's left eye (os) on (b)(6) 2018.It was later explanted on (b)(6) 2018 because the patient had a myopic shift of -1.00 when the goal was plano.There was no incision enlargement, no vitrectomy, and no sutures used.Visual acuity pre-operatively was 20/50 with 2400 glare vision and the visual acuity post-operatively was 20/50.The replacement lens was the same model, but different diopter of 20.5.Reportedly, there was no patient injury and the patient is doing fine post-operatively.The device was accidently discarded by the surgery center.No additional information was provided.
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