Expiration date: unknown, as the lot number was not provided.Concomitant medical products: zcb00 21.5 diopter intraocular lens, serial # (b)(4), handpiece serial # unknown.Device manufacture date: unknown, as the lot number was not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
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It was reported that a zcb00 21.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017 with use of a model 1mtec30 cartridge.Post-operatively, on the same day as surgery, the doctor reported the eye looked good.On post op day 1, there were corneal folds/inflammation.The patient also has (b)(6).The patient was on increased steroids, but with no or slow improvement of the diagnosed condition as of (b)(6) 2017, and therefore, a topical antibiotic, besivance, was increased.In addition, omidria was given to the patient.Reportedly, the doctor noticed this case seemed more c/w tass (toxic anterior syndrome) like presentation, and the patient had significant endothelial folds-edema, had fibrin.Routine case, nothing out of the ordinary.No additional information was provided.This report represents the cartridge and a separate report will be provided for the intraocular lens.
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