The device was discarded by the user facility and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.The event was attributed to a combination of patient movement during the procedure and a very dense cataract with weak zonules, which predisposed the patient, and a lack of insurance coverage for general anesthesia which was warranted for the dense cataract.There was no report of a device malfunction.Capsular bag damage and vitreous loss are inherent risks of cataract surgery.(b)(4).
|
A patient with a very dense cataract and weak zonules underwent cataract surgery on (b)(6) 2018 where the leep device was used to section the cataractous lens into fragments.The surgeon requested general anesthesia because of the dense cataract and anticipated procedure length, but the insurance company only covered local anesthesia.During the procedure while the surgeon was bisecting the nucleus and retracting the loop, the patient abruptly moved his head and the loop of the leep device inadvertently caught the capsulorhexis and caused a rent.The surgeon attempted to mitigate the damage, but the capsular tear extended during phacoemulsification and secondary surgical intervention was required (extracapsular cataract extraction with a vitrectomy) and a 3-piece intraocular lens was implanted.The patient's postoperative best corrected visual acuity (bcva) is 20/50.
|