Explant date: if explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site as the lens remains implanted; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, no definitive 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 an intraocular lens (iol) was rotated twice, therefore, the patients eye had some swelling.Through follow-up, it was learned during the initial procedure, the surgeon could not align the dots of the lens while in the eye, therefore, the surgeon had to rotate the lens.The lens was rotated again, because the manipulation of the lens in the eye affected the visual acuity.The lens remains implanted.The patient outcome was unknown as the surgeon had not seen the patient for a follow-up visit yet.No additional information was provided to johnson & johnson surgical vision.
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