The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection, functional testing, then disassembled for internal inspection.There was no damage or device malfunction identified and the device met specifications and performed as intended.The published literature was reviewed for comparison of the functional test results for forced occlusion response; the investigation data shows the device operates within the same expected ranges for similar marketed phacoemulsification devices.The surgical video was provided to the manufacturer for review and the following summary represents the medical review by the company medical affairs director / ophthalmologist.A manual circular capsulorhexis was created and the surgeon made 3 miloop cuts to separate the cataract into 6 sections and the miloop device was removed from the eye.No difficulty or problems with the technique was noted and the miloop is not considered a contributing factor for this event.Micor extraction (aspiration) was initiated and within 10 seconds, a posterior capsular tear appeared to occur at the 11 o'clock position.The surgeon appeared to have the micor extractor positioned at the center cortex cutting into a section of posterior sclerotic nucleus when the cutter reached the posterior and a surge event occurred.Approximately 15 seconds later, a lens fragment dropped into the vitreous cavity.The remainder of the surgery (cataract removal, anterior vitrectomy, iol implantation) was uneventful.Posterior capsular bag tears are an inherent risk of cataract surgery.The micor extractor device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).
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A 66-year-old male patient underwent cataract surgery in the right eye on (b)(6) 2023 where the miloop lens fragmentation device was used to section the cataractous lens into 6 fragments and the micor lens fragmentation system (extractor and drive) was subsequently used to remove the cataractous lens fragments.Within the first 10 seconds of initiating aspiration with the micor extractor, the posterior capsule tore at the 11 o'clock position.The tear resulted in vitreous fluid loss, vitreous hemorrhage, and a portion of the lens dropped into the vitreous cavity.An anterior vitrectomy was performed and a 3-piece intraocular lens was implanted in the sulcus.The surgeon attributed the capsular damage to a surge event.Patient follow-up information was requested from the surgeon.At the one-day postoperative visit, the patient presented with 2+ corneal edema, elevated intraocular pressure (iop), and decreased visual acuity (20/500).The patient was referred to a retina specialist and on (b)(6) 2023 the patient underwent retinal surgery remove the retained lens fragment(s) and address the vitreous hemorrhage.The patient's one-week ocular status was as follows - best corrected visual acuity (bcva): 20/450; iop: 42 mmhg; trace corneal edema.The patient remains under the care of the retina specialist and additional follow-up will be requested.
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