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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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-health care professional reported that during an intraocular lens (iol) implant procedure, trailing haptic folded wrong.There was no patient contact.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The used device was returned with the lens.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced the lens to mid-nozzle and has torn through the trailing optic edge material.The trailing haptic was misfolded, looped around the plunger tip.The distal area of the trailing haptic was extended backward along the right side of the plunger.The leading haptic was extended.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 trailing haptic was misfolded, looped across the front of the plunger tip.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol (intraocular lens) with the company preloaded delivery system, an 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.Haptic folding may be influenced by an intermittent plunger rate or if the operating room temperature is too high (> 23°c / 73° f).If the operating room temperature is too high lens folding consistency is negatively affected as the lens more adherent.This may inhibit lens advancement or contribute to incorrect haptic folding.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: 22961473
• Report Number: 1119421-2025-02385
• Device Sequence Number: 20933712
• Product Code: KYB
• UDI-Device Identifier: 00380652395236
• UDI-Public: (01)00380652395236(17)280308(11)250310(10)16009094
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 16009094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: OPHTEISBIO 1·6 - LOT # OPB1600006
• Patient Sex: Unknown