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	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that before intraocular lens implant procedure the surgeon noticed the intraocular lens haptic deformed or asymmetric.There was no patient contact.The procedure was completed with back up lens.
Additional Manufacturer Narrative
The device was returned loose in the carton.The lens stop and plunger lock were removed.The plunger was oriented incorrectly upon return.Inadequate viscoelastic was observed in the device.The plunger was advanced into the nozzle entry area and has underrode the lens.The lens was located on the plunger tip.The optic was crushed and torn by the advancing plunger.The trailing haptic was misfolded under and broken into multiple pieces.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was indicated.The trailing haptic was misfolded and broken into pieces due to a plunger underride.This haptic damage was most likely interpreted as the reported complaint of haptic deformed, asymmetric.The root cause for the reported event may be related to a failure to follow the instructions for use (ifu).An inadequate amount of viscoelastic was observed.The ifu instructs fully insert the ovd cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device.Fill the device until ovd can be observed flowing to the fill to line on the nozzle tip.This will require approximately 0.2 ml of ovd.Only use an company ovd qualified for use with the company pre loaded delivery system that has been allowed to come to the operating room temperature.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.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iq iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Upon return, the plunger was observed to be oriented incorrectly in the device.It cannot be determined if the plunger may have been inadvertently retracted outside of the device and reinserted incorrectly by the customer.Although the plunger orientation cannot be ruled out as a potential cause, it is unlikely that the device was manufactured incorrectly.Plunger placement is conducted with a plunger/main body assembly fixture.The fixture by design ensures the proper orientation and placement of the plunger in the device.Plunger underride may occur due to rapid advancement faster than the ifu recommended 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 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 allowing the plunger to underride the lens.If the operating room temperature is too high (more than 23 degree c or 73 degree 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.Top coat dye stain testing was conducted with acceptable results.File will be reopened if new information is received.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: 22210605
• Report Number: 1119421-2025-01672
• Device Sequence Number: 15618175
• Product Code: KYB
• UDI-Device Identifier: 00380652395243
• UDI-Public: (01)00380652395243(17)270910(11)240911(10)15919612
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 06/16/2025

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: 15919612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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
• Patient Sex: Unknown