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A health care professional reported that following an intraocular lens (iol) implant procedure, patient experienced presbyopia which was not corrected at all and the patient cannot read without additional glasses.Astigmatism was not corrected and the vision has worsened, previously patient could work on the computer without glasses but now glasses are needed.A stripe has appeared in the visual field on the left eye from the bridge of the nose to the outer corner of the eye, patient wanted to brush the stripe away as if it were a hair.Additional information was received and stated, on (b)(6) 2024 iol was implanted in the left eye.Two hours after the surgery, after removing the bandage from the eye, the first thing patient saw was a yellow arcuate stripe, which was located in the field of vision of the left eye and extended from the bridge of the nose to the outer corner of the left eye.From that moment until now, this stripe has been constantly present in the field of vision of the left eye.It does not shift anywhere, never disappears and does not depend on the time of day and lighting and does not depend on how patient adjust the eye, to a close distance or to a distance.On (b)(6) 2024, a control examination was carried out, where patient reported the stripe.Patient could not figure out how exactly to see with left eye due to the presence of this stripe.Patient medical record did not record a complaint about a stripe that was interfering with the vision, which is why patient constantly had the urge to either blink or unconsciously try to brush it away.On (b)(6) 2024, the next examination was carried out, where again patient reported all the deficiencies.These were not recorded in patient medical record.Vison in left eye was 1.0 (-1) near = 0.2, 50-60 cm 0.4, which in itself indicates that patient cannot read printed literature or read from a laptop or use a smartphone without glasses.Additional information was received, doctor said that these events do not pose a threat to the patients life and health and are also not clinically significant.The patient maintains high distance vision in the postoperative period.During the consultation before the operation, the patient chose to have the company intraocular lens implanted, the patient was given an explanation of the expected postoperative visual acuity and the need to use optical correction when working at close range.The patient has concomitant chronic diseases and recommended to consult related specialists.There are two medical device reports associated with this patient.This report is associated with the left eye.
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Additional information was received and stated, patient was not complaining about the lens itself but about the final result.Her doctor stated that the implanted lens cannot meet the requirements expected of a lens.According to the patient, the requirements are not being met as her vision had deteriorated (before it was plus 5, after deterioration by several times, now it was plus 0.3 which was insufficient for glasses free vision).For the left eye, immediately after surgery, she experienced an optical phenomenon in which a crescent shaped line constantly appears in front of her eye (she constantly feels the urge to brush it away, and its psychologically difficult for her to cope with).She had astigmatism before the surgery, but presbyopia was not corrected after the operation.
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