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	06/26/2025
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.Photos were provided.One photo displayed the end cap of the carton displaying the product information.The second photo displayed the yellow lens model placed onto a white material.There appears to be viscoelastic and a red tinged solution (possibly blood.One haptic was broken in the gusset area and not visible in the photo.The other haptic was broken in the haptic/optic junction.This haptic was also not visible in the photo.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the feet (haptic) broke off at the time of insertion.The lens was explanted during the same procedure and replaced with a lens of the same model and diopter from the same company.The surgery was completed on the same day.No unscheduled medication or unplanned medical or surgical procedure was necessary as a result of the event.The patient was not hospitalized.The surgeon's prognosis was unchanged, as the surgery was completed with a replacement lens.In the surgeon's opinion, since it was a pre-loaded lens, the event was assumed to be caused by a defect in the lens.
Additional Manufacturer Narrative
The lens was returned outside of the device taped to a sponge.Blood and viscoelastic was dried on the lens.One haptic was broken from the gusset area (not returned).A portion of the optic which included the other haptic was cut (not returned).This damage is typical of insertion and removal.The company device was returned loose in 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and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted back to mid-nozzle.No damage or abnormalities observed.A device history record review and a non-conformance review of the reported lot number was conducted.The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.The file indicated the use of qualified viscoelastic.The reported broken haptic was observed.The root cause could not be determined.The instructions for use (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.Broken haptics may occur: if the operating room temperature is too high (greater than 23 degrees centigrade / 73 degrees fahrenheit) 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 the device is overfilled with ophthalmic viscosurgical device (ovd) as this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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: 22610151
• Report Number: 1119421-2025-02061
• Device Sequence Number: 10106110
• Product Code: HQL
• UDI-Device Identifier: 00380652394772
• UDI-Public: (01)00380652394772(17)270926(11)240927(10)15928270
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 15928270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 72 YR
• Patient Sex: Male