The account reported of a very big post-op surprise on the right eye of a patient that was implanted with an intraocular lens (iol).The patient is a is post myopic (rk) radial keratotomy (8-cuts) who was implanted based on barret post rk formula targeting +0.12.3-weeks post-op manifest refraction (mrx) +3.25 sphere (sph) 20/20.The patient was very unhappy and wanted to have corrective surgery as soon as possible.The doctor was concern about the power of the lens.The date that the unexpected pos-op refraction issue first noticed was indicated to be on (b)(6) 2021; also confirmed on (b)(6) 2021.The iol was explanted in a secondary surgical procedure on (b)(6) 2021 as scheduled.The surgery was completed successfully using a replacement lens, model diu375, 27.5 diopter positioned at 040.There were no medical or surgical interventions required.There was no patient injury reported and patient outcome post-operative day-1 (pod1), uncorrected visual acuity (ucva) was reported to be 20/20-2.No further information was provided.
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Corrected data: upon further review, it was realized that the event should not have been reported since the patient with post refractive procedure rk (radial keratotomy) would require a different lens power to be calculated/used.In this case, the patient was initially implanted with a 23.5 diopter lens which was then exchanged for a 27.5 diopter.The iol replacement resulted in an ucva (uncorrected visual acuity) of 20/20-2.There were calculation issues with the lens implanted initially and the reported event was not due to the lens product problem or malfunction.Therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number 2020664-2021-07830.Additional information: section h3-other (81): the intraocular lens (iol) has not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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