MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT015
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported during intraocular lens (iol) implant procedure, during the lens implantation phase.After the lens left the cartridge, the plunger became stuck between the plunger and the cartridge neck.The lens was eventually implanted without damage.The procedure was completed on same day without any impact to the patient.Additional information has been requested.
Additional Manufacturer Narrative
A product 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Correction information was provided in h.11.This is a duplicate of manufacturer report number 1119421-2025-00105.No additional reports will be filed on this report number.Any additional information that is received will be reported on manufacturer report number 1119421-2025-00092.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 21110811
• Report Number: 1119421-2025-00105
• Device Sequence Number: 8719427
• Product Code: POE
• UDI-Device Identifier: 00380652421270
• UDI-Public: (01)00380652421270(17)280619(11)230622(10)15670325
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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 Model Number: DFT015
• Device Lot Number: 15670325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 06/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CARTRIDGE; UNSPECIFIED INJECTOR
• Patient Sex: Unknown