Weight & ethnicity: unknown; unable to make contact with patient.Date of event: unknown; unable to make contact with patient.But the best estimate date is between (b)(6) 2022 and (b)(6) 2022.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 it is still 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.A search of complaints related to this production order (po) was performed.The search revealed that there were no other complaints for this po.No escalation was required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that the patient is experiencing blurry vision, double vision, and dry eye in both eyes (ou) post intraocular lens (iol) implantation.The patient is additionally experiencing light sensitivity requiring them to wear sunglasses in their home ou.The patient has tried cleaning their eyelids and using multiple eye drops to include; serum drops, lotemax & refresh relieva.The patient reports their vision fluctuates from being fine to blurry.Currently there is no planned intervention.The iols are not returning as they remain implanted.This report represents the left eye (os).A separate filing will be submitted for the right eye (od).
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