Model Number AU00T0 |
Device Problems
Device Damaged by Another Device (2915); Scratched Material (3020); Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.2 complaints were reported.1 of the reported complaints are similar to the reported event for this complaint.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health care professional reported during the intraocular lens implantation plunger does not advance correctly and does not drag the lens forward well.Either it stays hooked or it goes up or down and a notch on the periphery of the lens that did not affect the optics was also observed.The lens was remain implanted with no impact on the patient.Additional information has been requested.
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Manufacturer Narrative
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On initial mdr the fda product problem code of 3020 was an error.It should have been 2915 on the original mdr ¿ (corrected information provided in h.6.) the manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Two videos were provided of the same device.The first video shows the device being held with the nozzle point up.An inadequate amount of viscoelastic was added to the device.The plunger is advanced with the device tip pointing up.It appears a plunger override or underride occurred as the lens reaches the nozzle entry area.The second video also shows the device being held perpendicular in a gloved hand with the nozzle pointing up.The plunger is advanced moving toward the right and appears to go over the optic.The plunger is pulled back and removed from the device.The plunger is placed back into the device and an attempt is made to advance the lens.The plunger is removed and replaced again.The lens is advanced almost to the fill line and the video ends.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.Based on review of the provided videos the root cause for the reported complaint appear to be related to a failure to follow the instruction for use ifu.Inadequate viscoelastic was placed in the device.Viscoelastic could be observed added to just past the nozzle entry area.The ifu instructs to fully insert the ovd cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device.Fill the device until ovd can be observed flowing to the ¿fill-to¿ line on the nozzle tip (diagram provided).This will require approximately 0.2 ml of ovd.Only use an company ovd qualified for use with the company delivery system that has been allowed to come to the operating room temperature.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to over/underride the lens.In addition the device was observed being held with in a vertical position with the nozzle pointed up.The device is intended to remain in a horizontal position throughout the process as per the diagrams provided in the ifu.The plunger was also observed to be retracted and completely removed from the device and reinserted (twice).Per the ifu, do not attempt to retract the plunger after the plunger lock has been removed or plunger damage may result.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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