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	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2024
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 facility representative reported with a description of problems in engaging the intraocular lens (iol).Additional information has been requested.
Additional Manufacturer Narrative
The company device was not returned for evaluation.Only the lens was returned taped to surgical gauzes, inside the device carton.Viscoelastic and adhesive was observed on the lens.No lens damage observed.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not identify a root cause for the complaint.Viscoelastic was dried on the lens.No lens damage observed.Not enough information was provided to determine if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the company intraocular lens (iol) with the company 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.A follow up attempt was made for more details of the event.No additional information has been provided at this time.The file will be reopened if 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: 18932060
• Report Number: 1119421-2024-00524
• Device Sequence Number: 18464450
• Product Code: KYB
• UDI-Device Identifier: 00380652394840
• UDI-Public: 00380652394840
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 07/26/2026
• Device Model Number: AU00T0
• Device Lot Number: 15691738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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