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	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the intraocular lens (iol) broke due to injector failure.Also, the two haptics were folded correctly but when injected inside one of the haptics was fractured.Additional information received stated that patient had right eye phaco surgery.The lens was removed and replaced with another lens in an initial procedure.There was no patient harm.
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).
Additional Manufacturer Narrative
The device was returned in an opened non-company peel pouch.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and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted back to the loading area.No damage observed.The lens was returned outside the device in the opened non-company peel pouch.Viscoelastic was dried on the lens.One haptic was broken in the gusset area (not returned).The optic was torn/cut into two portions, typical of insertion and removal.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was provided.The root cause could not be determined for the broken haptic.The lens with broken haptic damage was returned outside of the device.The broken haptic portion was not returned.The "injector failure" was not specified.The plunger was retracted upon return.The plunger position in relation to the broken haptic during advancement cannot be determined.The instructions for use (ifu) instructs: after the lens has been advanced to the nozzle 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.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.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 ( 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 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: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17676782
• Report Number: 1119421-2023-01557
• Device Sequence Number: 12376212
• Product Code: KYB
• UDI-Device Identifier: 00380652394888
• UDI-Public: 00380652394888
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 10/12/2023

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 Expiration Date: 06/15/2025
• Device Model Number: AU00T0
• Device Lot Number: 15430912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/04/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown