MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information has been received as the issue with leading haptic and there was no harm to the patient.
Additional Manufacturer Narrative
Additional information provided in b.5.,h.6.And h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The specific haptic issue was not provided.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 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.The ifu instructs: take at least 7 seconds to gently fold the iol by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the ¿fill-to¿ line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.5.,d.9., h.6.And h.11.The device was returned loose in a bag.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid nozzle.The plunger had under rode the lens, resulting in damage to the lens.The optic was misfolded upward and rotated counter clockwise toward the left side in the device.The trailing half of the optic was torn and broken by the advancing plunger.The trailing haptic was also misfolded under the optic and was broken in the gusset and distal area by the advancing plunger.The haptic was on top of the plunger.The leading haptic was in contact against the left side of the device, twisted backward in the gusset area, and extended into the nozzle tip.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.A qualified viscoelastic was indicated.The root cause could not be determined for the reported complaint of leading haptic positioned incorrectly.The leading haptic was positioned incorrectly due to a plunger underride.The optic and trailing haptic were also broken and positioned on top of the plunger.The ifu instructs to take at least 7 seconds to gently fold the iol by advancing the plunger forward in one smooth continuous motion until the front edge of the optic is even with the fill to line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important not to advance the plunger abruptly to fold the iol, as improper folding and lens damage may occur.This may result in the lens not releasing properly from the device.Plunger underride may occur due to rapid advancement faster than the ifu recommended rate 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.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).
Event or Problem Description
A nurse reported during an intraocular lens (iol) implant procedure, while the doctor was implanting the lens, the haptic was positioned incorrectly.A new lens was used instead to complete the surgery.Additional information was requested.
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).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 22054253
• Report Number: 1119421-2025-01443
• Device Sequence Number: 15426995
• Product Code: KYB
• UDI-Device Identifier: 00380652394864
• UDI-Public: (01)00380652394864(17)270512(11)240513(10)15851684
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: AU00T0
• Device Lot Number: 15851684
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/11/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/04/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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