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

Model Number	ACU0T0
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2025
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 healthcare professional reported that lens appeared hard and folded up on itself.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., d.10., h.3., h.6.And h.11.The device with the lens was returned loose inside the carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was pressed against the trailing optic edge.The lens was advanced to mid-nozzle.The optic right and left sides were folded inside the device correctly.The trailing haptic was folded correctly onto the optic.The leading haptic was extended with the distal portion of the haptic broken (returned adhered in dried solution to the exterior of the device).The nozzle tip was heavily stressed and slightly bent toward the left.The plunger was removed to evaluate.The plunger bottom flange was bent under.It is unknown if a previous plunger override or a previous plunger retraction with second advancement had occurred.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Topcoat 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.A non-qualified viscoelastic was used.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company intraocular lens (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.The optic was folded in the device with the trailing haptic in a correct position.The leading haptic was extended and broken.Based on the position of the lens inside the device, a previous plunger override may have occurred, resulting in the bent damage to the plunger tip and damage to the leading haptic.A plunger retraction and a second attempt to advance the lens may have then occurred, pressing the damaged plunger tip against the trailing optic edge, as observed upon return.Plunger override 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°c / 73° 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: INTRAOCULAR LENS
• 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: 23887125
• Report Number: 1119421-2025-03223
• Device Sequence Number: 18554229
• Product Code: HQL
• UDI-Device Identifier: 00380652395335
• UDI-Public: (01)00380652395335(17)280618(11)250620(10)16060838
• 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,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: ACU0T0
• Device Lot Number: 16060838
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALON PRO 10MG/ML
• Patient Sex: Unknown