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

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following day of an intraocular lens (iol) implant procedure, the patient experienced severe inflammatory response, exudative membrane around iol, fundus glow see hazy.Second follow-up on (b)(6)-situation was worsen, fundus not seen, severe exudation around iol in spite of steroids and cycloplegics.The patient had conjunctival inflammation, aqueous cell +2, aqueous fibrin-present.Additional information has been requested.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The provided photos were clinically evaluated.Given the limitations of two-dimensional and blurred images, the photos display varying degrees of anterior segment inflammation, ranging from quiet/mild to moderate.There is no evidence of severe anterior segment inflammation.While the anomaly observed within the pupil of the first photograph might represent the reported exudative membrane, the analysis of these three photographs cannot definitively confirm this finding.Additionally, the reported hazy fundus glow cannot be confirmed, as a fundus red reflex was not apparent in any of the three photographs examined.The product investigation could not identify a root cause for the reported complaint.The product was not returned.All intraocular lens (iols) are terminally sterilized with 100% ethylene oxide sterilization.Company uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.To enhance the photographic analysis of this reported event, it would be beneficial to receive stereoscopic images, additional photos taken from various angles, images capturing various depths, and/or video documentation for evaluation.The manufacturer internal reference number is: (b)(4).

• 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: 17458871
• Report Number: 1119421-2023-01395
• Device Sequence Number: 11437531
• Product Code: POE
• UDI-Device Identifier: 00380652421157
• UDI-Public: 00380652421157
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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 Model Number: DFT015
• Device Lot Number: 15287773
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male