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

Model Number	AU00T0
Medical Device Problem Codes	Failure to Deliver (2338); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported with a description of plunger stuck with unable to advance the lens.The procedure was completed with another iol.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.A photo was provided that displayed a partial view of the used device in front of a laptop keyboard.The device was shown from the thumb tab to the end of the tip.The lens stop and plunger lock were removed.The plunger had been advanced to mid-nozzle.The lens was visible at the fill line.Due to the clarity of the photo, the lens had haptic folded positions could not be determined.It cannot be determined if there was viscoelastic in the device.A small gap was visible at the back the door.No other determination can be made from the photo.Product history records were reviewed, and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Based on review of the provided photo the lens was advanced to the fill line.There did not appear to be a plunger over/underride.A root cause cannot be determined without physical evaluation of the sample.It is unknown if a qualified viscoelastic was used.The ifu (instructions for use) instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.The ifu instructs: 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.This will require approximately 0.2 ml of ovd.Only use an company ovd qualified for use with the company pre-loaded 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.The ifu instructs: take at least 7 seconds to gently fold the iol (intraocular lens) by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the ¿fill-to¿ line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21393230
• Report Number: 1119421-2025-00411
• Device Sequence Number: 8273535
• Product Code: KYB
• UDI-Device Identifier: 00380652394659
• UDI-Public: (01)00380652394659(17)270227(11)240229(10)15813891
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15813891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/09/2025
• Date Device Manufactured: 02/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown