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

Model Number	DFT015
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that after an intraocular lens (iol) implantation procedure, scratch of the intraocular lens was noticed.Additional information was requested and received stating that it was difficult to determine whether it was present before or during the surgery.
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).
Additional Manufacturer Narrative
Corrected information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens/cartridge/injector combination used.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A lens was returned in an unlabeled lens case.The lens was not the reported lens model.Clarification was requested if the reported lens was the replacement.It was stated the complaint lens was verified to be the reported lens.No information was provided to identify the returned lens.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The reported lens was not returned.The root cause for the reported complaint may be related to a failure to follow the ifu.A non-qualified viscoelastic was indicated.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.A lens was returned in an unlabeled lens case.The returned lens was not the reported lens.Clarification was requested if the reported lens was the replacement.It was stated the complaint lens was verified to be the reported lens.No information was provided to identify the returned lens.It was reported that the or nurse who delivered it at the time had resigned.No further information could be obtained.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating it was difficult for them to verify that it was the correct iol as it had been cut for removal.

• 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: 20357439
• Report Number: 1119421-2024-01943
• Device Sequence Number: 7208415
• Product Code: POE
• UDI-Device Identifier: 00380652421225
• UDI-Public: (01)00380652421225(17)260606(11)210608(10)15214820(21)15214820078
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/10/2025

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 Expiration Date: 06/06/2026
• Device Model Number: DFT015
• Device Lot Number: 15214820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 10/31/2024; 12/18/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/30/2024; 11/29/2024; 01/10/2025
• Date Device Manufactured: 06/08/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PRODUCT OF HANMI PHARM.
• Patient Sex: Unknown