MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problems Device Damaged by Another Device (2915); Scratched Material (3020); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

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.

Manufacturer Narrative

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).

Manufacturer Narrative

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).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14188166
• MDR Text Key: 289889104
• Report Number: 1119421-2022-00833
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394796
• UDI-Public: 00380652394796
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15307818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC.