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 Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2023
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 pharmacy student reported failure placement with the intraocular lens (iol) implant device.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The device was returned loose inside the carton.The plunger lock and lens stop have been removed from the device.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted back to mid-nozzle.No damage or abnormalities observed.The lens was returned inside a surgical glove.Viscoelastic was dried on the lens.The lens was removed from the surgical glove and cleaned with klrp for further evaluation.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.No lens damage was observed.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.It is unknown if a qualified product was used.The root cause could not be determined for the reported complaint.It is unknown what is meant by "failure placement".The specific issue was not specified.No damage or abnormalities observed with the device.The lens was returned in a surgical glove.The lens was removed from the glove and cleaned with klrp for further evaluation.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.No lens damage was observed.Not enough information was provided to determine if a qualified viscoelastic was used.The instruction for use (ifu) 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.Follow up attempts were made for more details of the event.No further information has been provided at this time.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: 18542177
• Report Number: 1119421-2024-00121
• Device Sequence Number: 8926125
• Product Code: KYB
• UDI-Device Identifier: 00380652394888
• UDI-Public: 00380652394888
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 02/06/2026
• Device Model Number: AU00T0
• Device Lot Number: 15585375
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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