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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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 healthcare professional reported that prior to an intraocular lens (iol) implantation procedure, the haptic was positioned forward and was completely twisted, affecting the anterior haptic.The lens did not come into contact with the patient, and the procedure was completed using a different iol.Additional information was 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 plastic bag.The plunger lock and lens stop had been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was at the trailing optic edge at mid-nozzle.The lens was advanced to the fill line.The trailing haptic was folded on the optic, and the leading haptic was extended.No problems were observed.A device history record review and a non-conformance review of the reported lot number were 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 qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.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 considered a product malfunction and are acceptable per the diagrams provided in the ifu.A straight leading haptic may occur: due to 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 device preparation and delivery, the leading haptic may begin to unfold.If the operating room temperature is too high (> 23°c / 73°f), lens folding consistency may be negatively affected.The lens becomes more adherent, which may inhibit lens advancement or contribute to incorrect haptic folding.Any of the above causes, individually or in combination, may have contributed to the reported event.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: 22726653
• Report Number: 1119421-2025-02161
• Device Sequence Number: 12848173
• Product Code: HQL
• UDI-Device Identifier: 00380652395403
• UDI-Public: (01)00380652395403(17)270310(11)240311(10)15815228
• 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): 10/16/2025

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: 15815228
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC OVD; PROVISC OVD
• Patient Sex: Unknown