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 Codes	Failure to Fold (1255); Device Damaged by Another Device (2915)
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 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 that during surgery, they noticed that the lens was really hard.Haptic broken during insertion.There was no patient contact.Additional information has been requested and received stating the surgery was completed with backup lens.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The used device with the lens was returned loose in the carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was in contact with the optic edge on the left side in the loading area.The lens was rotated completely sideways and partially advanced into the nozzle entry area.The leading haptic was folded onto the anterior optic surface.The trailing haptic was misfolded under the optic and broken at the gusset area.No damage was observed to the device.The nozzle was removed and cleaned for further evaluation.The lens was removed during the cleaning.Top coat dye stain testing was conducted with acceptable results.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.Viscoelastic information was not provided.It is unknown if a qualified product was used.The root cause cannot be determined for the reported complaint.The lens was mispositioned in the device, partially advanced into the nozzle area.The misfolded position of the trailing haptic under the optic could only occur due to a previous plunger underride.A plunger underride during the delivery attempt may have been interpreted by the customer as the reported complaint of ¿lens really hard¿.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company 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.Plunger underride may occur: due to rapid advancement faster than the ifu recommended rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If the operating room temperature is too high (> 23 degree c / 73 degree f) 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.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: 22936114
• Report Number: 1119421-2025-02365
• Device Sequence Number: 9783706
• Product Code: KYB
• UDI-Device Identifier: 00380652395250
• UDI-Public: (01)00380652395250(17)270922(11)240923(10)15922922
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: 15922922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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