The reference (b)(4) has been allocated to this case by rayner.The event description provided by the distributor states that the haptic broke and the capsule ruptured during implantation resulting in the lens falling into the vitreous.The surgical procedure was extended and a retinal specialist performed a vitrectomy.The fact that the lens was delivered with a broken haptic may suggest that the lens became trapped during injection and that continued depression of the plunger has caused faster expulsion of the iol from the injector resulting in pc rupture.The product is not available for return in this case.It was discarded following use/explant.(b)(4).Rayner is continuing to follow-up with its sales agent to obtain additional information (including patient medical history, as there are certain conditions that may make a patient more pre-disposed to pc rupture) to facilitate further investigation of this event.This is an isolated report.A review of existing vigilance data confirms that no other incidents, of any type, have been received against the rayone emv rao200e batch 031164682.Our review of production records for the rayone emv rao200e batch 031164682 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from this batch were within tolerance, met specification criteria and were without defects.
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