Information unknown/ not provided per country's personal data privacy legislation/policy.Date of event: unknown, not provided.The best estimate date is between (b)(6) 2021.Explant date: lens remains implanted; therefore, not explanted.(b)(6).The intraocular lens (iol) is not returning for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, the information was not available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that in (b)(6) 2021, a patient had an eyhance intraocular lens (iol) implanted in both eyes.The target refraction was emmetropia with slight monovision.Patient has had several regular doctor's visits due to experiencing temporal, crescent-shaped, pulsating shadows more so in the left eye than the right.Patient's daily activities are significantly impacted as patient provided being severely disturbed.Account indicated that the shadow on the left eye partially extend into the visual center; therefore, restricting the patient so much that they have trouble at work.The doctor's best diagnosis is negative dysphotopsia.The refraction was at the exact targeted values of -0.11 for the right eye and -0.44 for the left eye.Patient was given maxidex 4 times a day for a total of 4 weeks as part of the normal standard of care.The lenses remain implanted.No further information was provided.This report is being filed for the patient's right eye.A separate report is being filed for the patient's left eye.
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