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

Model Number	DFT515
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.An attached photo shows what appears to be the lens inside an eye with what appears to be a deep scrape mark near the optic edge.We can not confirm the damage without a physical sample evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during a cataract extraction with an intraocular lens iol implant procedure, lens mark was noticed on implantation.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The product was not returned.A photo was provided that shows what appears toe be a scrape mark near the outer edge of the optic.Product history records were reviewed and documentation indicated the product met release criteria.The indicated company cartridge are qualified.A qualified viscoelastic and handpiece were indicated.The lens remains implanted.Based on review of the provided photo, the lens appeared to have a scrape mark near the edge.The root cause for the damage could not be determined from the photo.This type of damage may occur if inadequate viscoelastic was placed in the cartridge and/or if the lens was advanced too rapidly.The instruction for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC 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: 16723897
• Report Number: 1119421-2023-00636
• Device Sequence Number: 12586006
• Product Code: POE
• UDI-Device Identifier: 00380652422499
• UDI-Public: 00380652422499
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 06/14/2026
• Device Model Number: DFT515
• Device Lot Number: 15218468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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: DUOVISC; MONARCH CARTRIDGE; MONARCH III INJECTOR; PROVISC
• Patient Sex: Unknown