Posterior capsule (pc) tear is a potential consequence of cataract extraction.Predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity [ie.Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis], poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement.The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus.These conditions may arise either because of the ocular anatomy, or because of surgical technique.There is no evidence contained within the reported information at this time that indicates that the design or performance of the system had any effect on the integrity of the posterior capsule.The system operator¿s manual includes a warning: ensure that appropriate system parameters and system settings are selected prior to starting the procedure.Adjusting aspiration rates or vacuum limits above the preset values, or lowering the intraocular pressure (iop) or iv pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized.Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.The system serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.Due to insufficient information, the root cause could not be identified conclusively.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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