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

Model Number	DFT415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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.There have been 2 other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported following an intraocular lens implant procedure, the patient had epithelial ingrowth over rexis in both eyes.On one eye the doctor have scraped the epithelial cells away, but it came back.Additional information has been requested and received which states the surgeon don¿t think it is anterior capsule opacification (aco, because it is like tissue ingrow from the rexis and in to the center, but with a free center.There are 2 files associated with the events.This files is associated with the right eye.
Additional Manufacturer Narrative
On initial mdr the d.4.(lot provided) was an error.It should have been asku on the original mdr.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: 13597637
• Report Number: 1119421-2022-00355
• Device Sequence Number: 5947065
• Product Code: POE
• UDI-Device Identifier: 00380652422222
• UDI-Public: 00380652422222
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2026
• Device Model Number: DFT415
• Device Lot Number: 15178763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female