If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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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Was reported that a zxr00 20.0 diopter intraocular lens was explanted from the patient¿s right eye due to myopia.The patient is not bothered by any dysphotopsia and loves her first eye surgery with a the symfony lens, but the eye turned out plano so the doctor attempted to improve her near vision by implanting a piggy back lens.This resulted in the patient being too myopic.Therefore, the doctor decided to explant the iol and replaced it with the same model but a lower diopter 19.0.A vitrectomy was required.Thru follow-up the customer also explained that the patient¿s capsule did not tear, patient had a 1-2 clock hour zonluar dialysis with a few vitreous strands entering the anterior chamber that required a limited anterior vitrectomy.The lens was perfectly stable and on axis.Further follow-up was conducted but the customer did not have any more information regarding this issue.Reportedly, the patient is doing well.No further information was provided.
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