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	Insufficient Information (4580)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device with the lens was returned loose inside the carton.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 to mid nozzle.The trailing haptic was folded on the optic.The leading haptic was extended with distal haptic tip oriented toward the nozzle tip.Both haptic positions are acceptable.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.No problems were observed with the returned device.The plunger, lens and haptic positions were acceptable.The leading haptic was straight.The straight leading haptic position may have been interpreted as the reported haptic complaint.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the 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, or if the operating room temperature is too high greater than 23c or 73f 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.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implantation procedure, the lens haptic appeared twisted.A backup lens was used to complete the surgery.Additional information was requested.

• 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: 22496556
• Report Number: 1119421-2025-01931
• Device Sequence Number: 20637532
• Product Code: KYB
• UDI-Device Identifier: 00380652395182
• UDI-Public: (01)00380652395182(17)270307(11)240308(10)15822281
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 15822281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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 OVD
• Patient Sex: Unknown