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	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during surgery, he noticed after insertion a small black line (like a small thread) at the edge of the central element.Test with a spatula to see whether it was a deposit on the posterior or anterior surface: negative.Suspected material defect, removal of the lens after cutting and implantation of the standby iol.Whether the patient is harmed by the prolonged anterior chamber manipulation (e.G.Endothelial cell loss) or whether short-term problems such as pressure increase due to the increased use of viscoelastics (discovisc) will occur, he cannot yet say.Additional information has been requested and received stating that a non company injector was used.Regarding patients outcome it was reported that it was too early for final assessment.
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).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the distal area tip area (not returned).The optic was cut from edge past center of the lens.This damage appears to have occurred during the lens removal.The lens was cleaned with klrp for further evaluation.A line was observed on the anterior surface of the optic near the center.This line has the appearance of excess monomer.Complaint and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and viscoelastic.The handpiece indicated is not qualified for the product combination used.Based on the review of the returned sample, the root cause for the reported issue was determined to be manufacturing related.The observed line on the optic was not foreign material or a scratch.The line was determined to be a line of excess monomer (lens material).This excess strand of monomer was most likely introduced to the optic surface during the wafer separation operation.The line of excess monomer (lens material) would not meet alcon¿s cosmetic release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating based on physician's opinion, the operated eye would not suffer any permanent damage as a result of the iol removal and secondary implantation.

• 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: 18391945
• Report Number: 1119421-2023-02212
• Device Sequence Number: 2932494
• Product Code: POE
• UDI-Device Identifier: 00380652421232
• UDI-Public: 00380652421232
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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 Model Number: DFT015
• Device Lot Number: 15287810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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: ASICO ROYALE INJECTOR.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.
• Patient Age: 68 YR
• Patient Sex: Unknown