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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during intraocular lens (iol) implant procedure, the plunger was bent / plunger slides under/over lens.Additional information has been requested and received stating no hospitalization necessary as a result of the event and the event did not result in any impairment of the patient.Additional information was requested and received stating that there was patient contact, and the procedure was completed on the same day with the same iol, without replacement.
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.Two identical photos were provided.The photo showed the plunger full advanced outside of the nozzle tip.The view was mid-nozzle to end of the plunger tip.No damage or abnormalities were observed.The tip flanges did not appear damaged.The upper flange is intended to be angled, this is not damage.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.4., d.9.And h.3.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The device was returned.The plunger lock and lens stop had been removed.Viscoelastic was observed in the device.The plunger had been fully advanced outside the nozzle tip.Both tip flanges were damaged, folded back on the plunger.The upper flange was also torn.This type of damage can occur if a plunger over or underride occurs.The lens was not returned.The plunger position in relation to the lens during advancement cannot be determined.The returned device did not match the provided photo.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.It is unknown if a qualified viscoelastic was used.The root cause could not be determined.The returned device was microscopically evaluated.The lens had been delivered.The plunger tip was damaged.The upper and lower flanges were bent back.The upper flange was also torn.This type of damage can occur if there is a plunger over/underride.Plunger tips are 100 percentage inspected during the manufacturing process.The extensive damage observed would not have met release criteria.It is unknown of qualified viscoelastic was used.The instructions for use (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 ifu instructs: fully insert the ovd 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 milliliters (ml) of ovd.Only use a 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: 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.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.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: 24016661
• Report Number: 1119421-2026-00066
• Device Sequence Number: 10719874
• Product Code: KYB
• UDI-Device Identifier: 00380652395274
• UDI-Public: (01)00380652395274(17)280608(11)250610(10)16053391
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 16053391
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 02/19/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/12/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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: UNKNOWN VISCOELASTIC
• Patient Sex: Male