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 Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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 that during intraocular lens implantation surgery when lens being loaded surgeon noticed that the haptic was broken in the delivery system.Surgery was completed on the same day.There was no patient contact.
Additional Manufacturer Narrative
The sample was not returned.Three photos were provided in the supporting documentation.Photo one shows the used device held in ungloved fingers.The device was shown just before the loading area throughout the tip.The posterior surface was facing the camera.The plunger appeared to be oriented correctly.There appears to be viscoelastic in the device.The plunger was advanced beyond mid-nozzle and appeared to have overrode the lens.The lens was advanced into the nozzle entry area.The leading haptic was extended and trapped underneath the plunger.The trailing haptic position or condition cannot be determined from this photo.Photo two showed the used device from an anterior view held in ungloved fingers.The lens stop was removed.There appears to be viscoelastic in the device.The plunger was advanced beyond mid-nozzle and appeared to have overrode the lens.The lens was advanced into the nozzle entry area.The leading haptic was extended and trapped underneath the plunger.The trailing haptic was observed to the left of the plunger, positioned over the optic and appeared to be broken in the gusset area.The trailing haptic appeared to be extended backward with the distal haptic tip partially in the loading area.Photo three showed the used device from a side view held in ungloved fingers.The plunger and lens location and condition were previously described in the photo one and photo two review.No further determinations can be made from the photos.A physical sample would be necessary to make further determinations.A device history record review and a non-conformance review of the reported lot number was 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 used.The product investigation could not identify a root cause for the reported complaint.Based on our observation of the attached photos, there appeared to be clinical solution present in the device.The condition and position of the haptics inside the device cannot be determined from the photos.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.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: 23595219
• Report Number: 1119421-2025-02981
• Device Sequence Number: 9388807
• Product Code: KYB
• UDI-Device Identifier: 00380652394796
• UDI-Public: (01)00380652394796(17)271030(11)241031(10)15941935
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 15941935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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: VISCOAT OVD
• Patient Sex: Unknown