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	Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.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.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported during cataract phacoemulsification and intraocular lens (iol) implant procedure, the injector does not properly load the lens, preventing its implantation during loading.The procedure was completed using another lens of the same type with no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.The device and the lens were returned loose in the lens carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger was fully advanced with the plunger tip outside the nozzle tip.No issues or abnormalities observed.The lens was returned outside the device loose in the carton with the device.Viscoelastic was dried on the lens.The lens was cleaned with klrp for further evaluation.Both haptics were pliable when manipulated.No issues observed.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A dimensional (plan view) inspection was conducted and the lens met specification per the approved (plan view) template.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.Associated viscoelastic was not provided.It is unknown if a qualified product was used.No problems were observed with the returned device or lens.Associated viscoelastic was not provided.It is unknown if a qualified product was used.The instructions for use (ifu) instruct: during device preparation and implantation of the company iq iol with 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.Only use an alcon ovd qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.The ifu instructs: take at least 7 seconds to gently fold the intraocular lens (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.After the lens has been advanced to the ¿fill-to¿ line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the ¿fill-to¿ line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome.The manufacturer internal reference number is: 2026-05804.

• 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: 24320684
• Report Number: 1119421-2026-00292
• Device Sequence Number: 21310263
• Product Code: KYB
• UDI-Device Identifier: 00380652394819
• UDI-Public: (01)00380652394819(17)280728(11)250730(10)16085563
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/06/2026

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: 16085563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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