It was reported that a zxt150 18.5 diopter intraocular lens (iol) was implanted on (b)(6) 2017.It was later explanted on (b)(6) 2017 because the wrong power was used.Further information provided indicated an unexpected post-op refraction post implant and that the patient was not happy with their vision.At explant there was no incision enlargement, vitrectomy, or sutures used.The lens was replaced with the same model, but different diopter of 16.5.Reportedly, there was no patient injury.No additional information was provided.
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Device available for evaluation: yes, returned to manufacturer on: 01/12/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
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