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	08/01/2025
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 during an intraocular lens (iol) implant procedure, the plunger was bent and overrides the lens.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in d.9., e.1., h.3., h.6.And h.11.The device with the lens was returned in the blister tray 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and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted into the loading area and appears to have previously under rode the lens.The lens was advanced into the nozzle, pressed against the inner ceiling, typical in appearance to a previous plunger underride.The optic was slightly rotated, and torn.The leading haptic was bent back along the left side of the device, between the lens and the device wall.The trailing haptic was misfolded, extended backward, pressed up, similar in appearance to being positioned on the plunger.The plunger was removed and evaluated.The plunger was not bent.The plunger was reinserted into the device with no abnormalities observed.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.There was no damage observed to the plunger.Evidence of a previous plunger underride was observed, resulting in lens mispositioning and lens damage.The plunger underride was most likely interpreted as the complaint and contributed to the appearance of a bent plunger to the customer.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 iol 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.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°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: 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: 22921875
• Report Number: 1119421-2025-02352
• Device Sequence Number: 21390071
• Product Code: KYB
• UDI-Device Identifier: 00380652395243
• UDI-Public: (01)00380652395243(17)280401(11)250403(10)16017240
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 16017240
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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: EYEFILL C OVD
• Patient Sex: Unknown