An ophthalmic surgeon reported that during a cataract surgery with intraocular lens (iol) implant, the surgeon had to remove the lens from the eye after implantation.The first haptic came out oriented downwards, towards the capsule and therefore the surgeon did not completely push the piston.The second haptic entered the eye nonetheless.The iol had to be positioned again in order to place it in the bag.The second haptic was still folded.A capsular rupture occurred on 180 degrees.The surgeon had to remove the iol in order to proceed to a vitrectomy.Several attempts to obtain additional information have been made with no response to date.
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Evaluation summary: product evaluation: the device was returned loose in the carton.Viscoelastic is dried in the device.The plunger is oriented correctly.The lens was returned adhered to the outside of the loading area door.No damage or abnormalities are observed.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic used was not provided.It is unknown if a qualified viscoelastic product was used in the device.The root cause for the complaint of leading haptic implanted downward, bag broken by trailing haptic could not be determined.The lens was returned outside of the device.No abnormality or damage was observed.A straight leading haptic is an acceptable position per the dfu and is not a malfunction of the lens/device.The dfu instructs if the leading haptic is straight or looped and extended in front of the lens, rotate device to be bevel left before advancing plunger to ensure the leading haptic is correctly placed in the capsular bag.As the leading haptic begins to exit the nozzle tip, place the leading haptic into the capsular bag in its correct orientation, and continue to slowly advance the plunger to deliver the lens.As the optic exits the nozzle, rotate the device back to center or slightly bevel right if needed to ensure the lens unfolds anterior side up within the capsular bag.(b)(4).
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