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
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
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).
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 plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger has advanced the lens to mid-nozzle and has overrode the lens.The lens was located underneath the plunger tip.The leading haptic was extended.The trailing haptic was folded into the optic fold.The plunger was retracted from the device and evaluated.The plunger was not bent.The plunger was reinserted into the device and was advanced with no abnormality observed.The nozzle was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.A plunger override was observed.The plunger was removed and evaluated.The reported bent plunger was not observed; however, due to the plunger override the plunger may have appeared bent 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: 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.Plunger override may occur: due to rapid advancement faster than the ifu recommend 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: 22921878
• Report Number: 1119421-2025-02351
• Device Sequence Number: 10231215
• Product Code: KYB
• UDI-Device Identifier: 00380652395298
• UDI-Public: (01)00380652395298(17)280309(11)250311(10)16008992
• 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: 16008992
• 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: 03/11/2025
• 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