If implanted or explanted, give date: not applicable as this is not an implantable device. device evaluation: the 1mtec30 cartridge was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the 1mtec30 cartridge were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been 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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It was reported that on (b)(6) 2018, while inserting tecnis monofocal intraocular lens (model zcb00 +20.5 diopter) the unfolder cartridge (model 1mtec30) partially delivered the lens and the lens got stuck in cartridge.This lens was removed and reportedly doctor again tried to insert another tecnis monofocal intraocular lens (model zcb00 +20.5 diopter) using another unfolder cartridge (model 1mtec30), however this lens too got partially delivered and then got stuck in cartridge.A third tecnis monofocal intraocular lens (model zcb00 +20.5 diopter) was implanted without any issue.There was no patient injury reported.No further information provided.This report is for first attempt.Separate report is being submitted for the second attempt.
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