MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	ACU0T0
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 non-healthcare professional reported during intraocular lens (iol) implant procedure, the plunger did not engage with patient contact.The procedure was not completed on same day without any harm to the patient.Additional information has been requested.
Additional Manufacturer Narrative
The device with the lens was returned in the blister tray inside the carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger was retracted into the barrel of the device.The lens was partially advanced into the nozzle entry area.The lens was misfolded up in the device.The trailing haptic was misfolded, completely tucked under the optic in the loading area.The leading haptic was folded toward the leading optic edge in the nozzle entry area.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause was most likely related to a failure to follow the instruction for use (ifu).An inadequate amount of viscoelastic was observed.The ifu instructs: fully insert the ophthalmic viscosurgical device (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 milliliters (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.The lens was partially advanced into the nozzle entry area.Evidence of a previous plunger underride was observed.The lens was pressed up and the trailing haptic was misfolded, completely tucked under the optic.This was most likely interpreted as the reported complaint.Plunger underride may occur: due to rapid advancement faster than the ifu recommended 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 underride the lens.If the operating room temperature is too high (greater than 23 degrees centigrade / 73 degrees 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.Topcoat dye stain testing was conducted with acceptable results.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has indicated that they have answered the questions that they felt were "relevant" and they request company to replace this lens.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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: 21700813
• Report Number: 1119421-2025-00849
• Device Sequence Number: 15415053
• Product Code: KYB
• UDI-Device Identifier: 00380652395359
• UDI-Public: (01)00380652395359(17)270327(11)240328(10)15827406
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: ACU0T0
• Device Lot Number: 15827406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC.
• Patient Sex: Unknown