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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
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 an intraocular lens (iol) implant procedure, the haptic was twisted inside the injector.There was no patient contact.Additional information was received by stating, another unspecified lens was used to complete the procedure.There was no patient harm.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The device with the lens was returned in the blister tray in the carton.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger has advanced the lens to the fill line.The leading haptic was extended with the distal area extended beyond the nozzle.The distal haptic tip was severed.The trailing haptic was broken in the gusset area and was misfolded, looped across the plunger tip with the distal haptic tip oriented backward along the right side of the plunger.The nozzle was removed and cleaned for further evaluation.The lens was removed during 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.A non-qualified viscoelastic was indicated.The root cause was most likely related to a failure to follow the ifu (instruction for use).An inadequate amount of viscoelastic was observed in the device and a non-qualified viscoelastic was indicated.The trailing haptic was observed to be misfolded, looped across the front of the plunger and broken in the gusset area.The ifu instructs: fully insert the ovd (ophthalmic viscosurgical device) 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 an company ovd qualified for use with the company 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: during device preparation and implantation of the company iq 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.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.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 ifu instructs: after the lens has been advanced to the nozzle 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.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.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, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.Top coat 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: 24588084
• Report Number: 1119421-2026-00528
• Device Sequence Number: 21142082
• Product Code: KYB
• UDI-Device Identifier: 00380652395243
• UDI-Public: (01)00380652395243(17)280707(11)250709(10)16070744
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 16070744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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: NUVISC.
• Patient Age: 78 YR
• Patient Sex: Female