Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2017.If explanted, give date: not applicable, remains implanted in the eye.(b)(4).Device evaluation: product testing could not be performed because the product was not returned as it is still implanted.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
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It was reported that patient¿s vision has been bad since surgery in (b)(6) 2017, recently was told by his healthcare provider that he has astigmatism in his left eye when he thought it should have been fixed with the surgery, he can¿t get eye glasses because his prescription keeps changing and is not happy with the lenses.Reportedly he was recommended to use reading glasses.He assumes that his lens may have shifted.Patient is experiencing scattered light, halos, starbursts, double vision especially at night.He can see of about 4 feet away, anything closer is blurry, he can watch television ok, he cannot read a book, he can use his ipad, but needs to zoom all the way in to see it.He really needs glasses, but with his prescription constantly changing he can¿t afford to buy new glasses every time.Additional information was received, and it was learnt that his astigmatism was never resolved, and his daily activities are issue and his night vision is terrible.Patient thinks that his lens in both eyes has rotated due to which he is having this issue.Patient reported that visual acuity issue was right away after the surgery and had become worse after the left eye surgery.This event will capture information for left eye of the patient.A separate report is being submitted for patient¿s right eye.No further information provided.
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