Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.(b)(4).Device evaluation: the product was not returned to the manufacturing site.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that the zxr00 19.0 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to the patient ending up myopic.There was no incision enlargement, no vitrectomy and no sutures used.The replacement lens was the same model, but different diopter of 18.0.Reportedly, the patient is doing okay post-operatively.No additional information was provided.
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