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 Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that after an intraocular lens (iol) implantation procedure physician noticed a small piece of what he thinks could potentially be plastic on the patients cornea.He was concerned at the time that it appears like it could be a piece of plastic of the lens injector.He has inspected the injector under the microscope and thought there was possibly an area of suspicion but was unsure.He flushed area, was unable to remove foreign body but does not believe will cause issue.Additional information was requested.
Additional Manufacturer Narrative
The device was returned loose in a plastic tray.The plunger lock and lens stop were removed.The plunger was oriented correctly.Small amount of viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.The nozzle tip was bent backward.This damage may have occurred during transit as the device was unsecured in the tray.No other damage was observed.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.No internal damage was observed.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 for the reported foreign body on the patient¿s cornea cannot be determined.The material was not returned.A root cause cannot be determined without physical examination of the reported material.The only damage observed to the device was to the nozzle tip.The end of the tip was bent backward upon return as if pressed against a hard surface.This damage may have occurred during transit as the device was unsecured in a plastic tray.Top coat dye stain testing was conducted with acceptable results.Viscoelastic was not provided.It is unknown if a qualified viscoelastic was used.The ifu (instruction for use) instructs: during device preparation and implantation of the company iol with the company 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 reporting facility has not provided any further information.File will be reopened if new information is received.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: 18462736
• Report Number: 1119421-2024-00035
• Device Sequence Number: 19624781
• Product Code: KYB
• UDI-Device Identifier: 00380652394741
• UDI-Public: 00380652394741
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 11/01/2025
• Device Model Number: AU00T0
• Device Lot Number: 15525153
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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: HEALON
• Patient Sex: Unknown