A physician reported that during a combined phacoemulsification and vitrectomy surgery for retinal detachment while using an ophthalmic console at the start of the sculpture, in the first groove in the lens, there was sudden hypothalamy (sic) with irreducible anterior incarceration /luxation of the lens.Surgeon suspect that the hypothalamy from an anterior thrust of the vitreous by increase of the patient's blood pressure.Later it was noticed that the irrigation from the console was off.Irrigation was reactivated however the patient has experienced rupture of posterior capsule (pc) and anterior capsule (ac).The patient had an acute ocular hypertonia postoperatively at night after the procedure despite preventive treatments.Additional information has been requested.Additional information received clarified that ophthalmic phacoemulsification (phaco) tip was also involved in the procedure and the phaco tip was clogged and a milky white solution came out of the tip.
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A sample was not received at the manufacturing site for evaluation for the report of there was hypothalamy, incarceration of the lens, posterior capsule and anterior capsule tear and the phaco tip was clogged with a white substance coming from the tip; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time the manufacturer internal reference number is: (b)(4).
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