A patient underwent cataract surgery in the right eye on (b)(6), 2023 where the micor lens fragmentation system (extractor and drive) was used to remove the cataractous lens fragments.During micor use, the patient's capsular bag was floppy and the high vacuum setting was used; the micor extractor caught the equator of the capsule which resulted in a small, circular posterior capsular tear.There was no vitreous loss and a 3-piece intraocular lens was implanted with optic capture.Preoperatively, the patient's best corrected visual acuity (bcva) in the operative eye was 20/40 +2, improving to 20/30 at the one-week postoperative visit.At this visit the patient was reported as healing appropriately and there has been no adverse impact on vision and no sequelae.
|
The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection and functional testing.There was no damage or device malfunction identified and the device met specifications and performed as intended.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).
|