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	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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 health care professional reported with a description of intraocular lens (iol) anterior haptic directed forward and completely twisted.There was no patient contact and no patient impact.Unspecified backup product was used.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The device with the lens was returned loose in a large plastic bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was at the trailing optic edge.The lens was advanced into the nozzle.The trailing haptic was folded on the optic.The leading haptic was extended.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was used.No problems were observed with the returned device.The plunger, lens and haptic positions were acceptable.The leading haptic was straight.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the instructions for use (ifu).A straight leading haptic may occur: due to the normal folding variations as indicated in the ifu diagrams.If the initial plunger advancement is faster than the recommended target, the leading haptic may be forced past the internal folding feature.If there is excessive delay between the device preparation and subsequent delivery the leading haptic may start to unfold.If the operating room temperature is too high (> 23 degree c / 73 degree f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement or contribute to incorrect haptic folding.Any of the above listed causes alone, or in combination, may create the reported event.The ifu instructs: insert the tip of the cartridge through the incision.Position the tip at the anterior capsule opening.If the leading haptic is looped or straight in front of the optic, rotate the nozzle clockwise as needed to be bevel left to facilitate placement of the leading haptic into its normal orientation in the bag.Slowly advance the lens until the optic is exiting the nozzle.Rotate the cartridge counter-clockwise towards bevel right as needed to place the lens anterior side up.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: 22069297
• Report Number: 1119421-2025-01456
• Device Sequence Number: 9338156
• Product Code: KYB
• UDI-Device Identifier: 00380652395335
• UDI-Public: (01)00380652395335(17)270915(11)240916(10)15919667
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 15919667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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.
• Patient Sex: Unknown