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 Codes	Device Difficult to Setup or Prepare (1487); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during intraocular lens implantation surgery, the haptic of the lens was tightly wedged between the plunger and cartridge.And the haptic broke off.There was no patient contact.
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
The used device was returned loose in the carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger appeared to be retracted into the loading area and potentially advanced again, tearing the trailing optic edge.The lens appeared to have been retracted or replaced into the loading area.The lens was slightly rotated upon return.One haptic was folded toward the optic.The other haptic was broken in the distal area.The broken haptic portion was not returned.The nozzle tip was slightly bent backward on the beveled anterior edge.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.Viscoelastic was not provided.It is unknown if a qualified product was used.The complaint was reported as ¿haptic was tightly wedged between the plunger and cartridge, it broke off, no patient contact¿.The lens was not tightly wedged upon return.A broken haptic was observed.The root cause cannot be determined for the reported complaint.It is unknown if a qualified viscoelastic was used.The ifu (instructions for use): during device preparation and implantation of the 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.The original location in the device where the haptic broke cannot be determined.The loading area location of the lens and plunger were most likely due to retraction or replacement into the loading area.It cannot be confirmed if the broken haptic was the leading or trailing haptic during initial advancement.The plunger position in relation to the broken haptic during advancement cannot be determined.The plunger appeared retracted and advanced again.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.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: 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: 23279323
• Report Number: 1119421-2025-02681
• Device Sequence Number: 5469844
• Product Code: KYB
• UDI-Device Identifier: 00380652394932
• UDI-Public: (01)00380652394932(17)270903(11)240904(10)15913647
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 15913647
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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