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

Model Number	AU00T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional had reported that during cataract surgery with intraocular lens (iol) implantation, one of the lens haptics became stuck in the injector piston and broke off.As a result, a new lens was implanted successfully.There was no patient contact and harm.
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).
Additional Manufacturer Narrative
Additional information was provided in d.9, h.3., h.6.And h.11.The device with a broken trailing haptic was returned in the blister tray in the carton the plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully advanced.The trailing haptic was trapped in the nozzle tip and broken at the gusset area.The gusset area of the haptic was slightly outside of the nozzle tip.The trailing haptic was straight, extended backward along the left side of the plunger.The distal tip of the trailing haptic was located at the wound guard of the device.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.A straight trailing haptic was observed trapped in the nozzle tip and was broken in the gusset area.The gusset area extended just outside the device and the distal tip was located at the wound guard.The plunger was fully advanced.The root cause may be related to a failure to follow the instructions for use (ifu).A straight trailing haptic is not an acceptable position for advancement per the ifu.The ifu instructs: after the lens has been advanced to the ¿fill-to¿ line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the ¿fill-to¿ line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.The ifu has an image for reference that displays a straight trailing haptic during advancement at the check point.An arrow is on this image pointing to the straight trailing haptic.The note on this ifu image states "do not proceed with a straight trailing haptic".It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, a 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.Broken haptics may occur: due to the use of a non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 22305948
• Report Number: 1119421-2025-01732
• Device Sequence Number: 8705520
• Product Code: HQL
• UDI-Device Identifier: 00380652394833
• UDI-Public: (01)00380652394833(17)270625(11)240626(10)15878931
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 15878931
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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