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 Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A healthcare professional reported that during intraocular lens (iol) implant procedure, haptic damaged or jammed in delivery system.The doctor had a hard time while advancing the plunger during iol loading.As they looked it up at microscope the lens was already stuck.As they had another iol as backup.So replaced with backup iol with same power.Surgery was completed and there was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.4., d.9., d.10., h.3., h.6.And h.11.The device with the lens was returned loose in the carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.No viscoelastic was observed in the nozzle or the tip of the device.Viscoelastic was only observed on/at the area of the stuck lens.The plunger was advanced over the lens.The lens was located just inside the nozzle entry area.The trailing haptic is misfolded and extended on the anterior of the optic due to the plunger override.The leading haptic was folded toward the optic.The photo provided appears to be of the returned sample.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause appears be related to a failure to follow the instructions for use (ifu).No viscoelastic was observed in front of the lens in the device.The ifu instructs: fully insert the ophthalmic viscosurgical devices (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 a 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.Plunger override may occur: due to rapid advancement faster than the ifu recommend rate.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 override the lens.If the operating room temperature is too high (more than 23 degree celsius / 73-degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.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: 21675089
• Report Number: 1119421-2025-00790
• Device Sequence Number: 7599747
• Product Code: KYB
• UDI-Device Identifier: 00380652394758
• UDI-Public: (01)00380652394758(17)260620(11)230622(10)15669953
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Expiration Date: 06/20/2026
• Device Model Number: AU00T0
• Device Lot Number: 15669953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT; UNSPECIFIED VISCOELASTIC; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown