MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Codes	Failure to Prime (1492); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
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 nurse reported that during cataract surgery with an intraocular lens (iol) implant procedure, the iol was crooked in the injector, it was difficult to push forward and could not be implanted.The cataract surgery was completed with a unspecified replacement product.There was no patient contact and no patient impact.
Additional Manufacturer Narrative
The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.No viscoelastic was observed in the nozzle or the tip of the device.Viscoelastic was only observed on/at the area of the lens.The plunger and lens were advanced to mid nozzle.The plunger was advanced over the optic edge.The lens was rotated/misfolded to the right side of the device.The leading haptic was misfolded back along the posterior surfaced on the left side of the nozzle.The trailing haptic was tucked in the optic fold.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results.Product history records were reviewed, and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).No viscoelastic was observed in the nozzle or the tip of the device.Viscoelastic was only observed on/at the area of the lens.The ifu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.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.Only use a company ophthalmic viscosurgical devices (ovd) qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.Lens may become stuck in the device: ¿ if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to become ¿stuck¿ in the device ¿ 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.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
After re-assessing this "complaint" with the current information "the iol was crooked in the injector, it was difficult to push forward with no patient contact", this event does not meet criteria for reporting as a malfunction.
Additional Manufacturer Narrative
Corrected information was provided in b.2., b.5.And h.11.Based on current information, after re-assessing this complaint, this event does not meet criteria for reporting as a malfunction.No further reports required.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 22459455
• Report Number: 1119421-2025-01879
• Device Sequence Number: 15516984
• Product Code: HQL
• UDI-Device Identifier: 00380652395281
• UDI-Public: (01)00380652395281(17)271202(11)241203(10)15959460
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15959460
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 10/10/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/19/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; REPLACEMENT LENS: UNSPECIFIED IOL
• Patient Sex: Unknown