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	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, during intraocular lens implantation surgery, the injector mismatched at syringe level.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The device with the lens was returned loose in the carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced the lens into the nozzle entry area.The plunger tip was pressed against the trailing haptic at the far end of the loading area.The trailing haptic was misfolded across the front of the plunger.This may have been interpreted as the reported complaint "injector mismatch at syringe level".The cannula port for the syringe of viscoelastic as located directly above the misfolded haptic.The leading haptic was extended in the nozzle.The nozzle of the device was verified to be fully seated onto the device.The nozzle of the device was also verified to be the correct nozzle for this product.The plunger was removed to evaluate.The upper and lower flanges were slightly bent.The plunger was re-inserted into the device with no difficulty.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported complaint of "injector mismatch at syringe level".Follow up attempts were made for clarifications.No further clarifications were provided.The nozzle of the device was verified to be fully seated onto the device.The nozzle of the device was also verified to be the correct nozzle for this product.The blue injector/plunger was slightly bent at both flanges.If this was the complaint, the upper flange may bend during lens advancement as it is flexible.This can result if a plunger over or underride occurs.Damage to the lower flange would indicate a plunger over or underride occurred.Due to the condition of the returned sample we are unable to determine when/how the damage may have occurred.The trailing haptic was misfolded across the plunger at the far end of the loading area.The cannula port for the syringe of viscoelastic as located directly above the misfolded haptic.This may have been interpreted a part of the complaint description of "at syringe level".Haptic folding may be influenced by an intermittent plunger rate or if the operating room temperature is too high ( 23°c / 73° f).If the operating room temperature is too high lens folding consistency is negatively affected as the lens more adherent.This may inhibit lens advancement or contribute to incorrect haptic folding.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the lens with the 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.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: 18010600
• Report Number: 1119421-2023-01818
• Device Sequence Number: 20652223
• Product Code: KYB
• UDI-Device Identifier: 00380652394710
• UDI-Public: 00380652394710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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: 08/16/2025
• Device Model Number: AU00T0
• Device Lot Number: 15470918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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
• Patient Sex: Unknown