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	06/26/2025
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 health care professional reported that during intraocular lens (iol) implant procedure, the surgeon noticed that the lens did not progress forward and the plunger went over it.Surgery slightly delayed as a new lens was collected, it was completed safely with no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11 the product was not returned.Two photos of the device were provided.Both photos showed the device being held by an ungloved hand.The view was from the edge of the mylar to the end of the device tip.The plunger was oriented correctly.There appeared to be viscoelastic in the device.Due to the clear nature, we cannot confirm if adequate viscoelastic was in the device.The plunger had been advanced almost to mid-nozzle.Unable to discern the lens in the device due to the clear nature of the lens, the poor lighting, and the slight blurriness of the photos.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A non-qualified viscoelastic was indicated.The root cause for the reported plunger override may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was indicated.The product was not returned.Two photos of the device were provided.The view was from the edge of the mylar to the end of the device tip.The plunger was oriented correctly.The plunger had been advanced almost to mid-nozzle.Unable to discern the lens in the device due to the clear nature of the lens, the poor lighting, and the slight blurriness of the photos.The ifu states that during device preparation and implantation of the company preloaded delivery system, a 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 a company ovd qualified for use with the 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 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 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: 22577075
• Report Number: 1119421-2025-02022
• Device Sequence Number: 9457654
• Product Code: KYB
• UDI-Device Identifier: 00380652395373
• UDI-Public: (01)00380652395373(17)261205(11)231207(10)15764612
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: 15764612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/03/2025
• Date Device Manufactured: 12/07/2023
• 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: HEALON OVD.; UNSPECIFIED LENS.
• Patient Sex: Unknown