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

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Macular Edema (1822); Blurred Vision (2137)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that after bilateral implantation of an intraocular lens (iol) lens, 3 weeks after the first eye and 2 weeks after the second eye in post-operative visit, her visual acuity worsened and she was diagnosed with bilateral irvine gass macular edema.The patient's second eye was still unresolved with acuity of 0.7.In treatment.Additional information was requested.There are two medical device reports associated with this patient.This report is 1 of 2.
Additional Manufacturer Narrative
Correction provided in d.4.Additional information was added in h.3.,h.6.And h.11.The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.Associated products were not provided.The product investigation could not identify a root cause for the reported complaint.The product was not returned.No issues were reported during the lens delivery.It is unknown how the iol would contribute to this event.Information was provided that in the post-operative visit 3 weeks after the first eye and 2 weeks after the second eye, the patient was diagnosed with bilateral irvine gass.Irvine gas syndrome, also known as cystoid macular edema (cme), is a notable complication that can occur after any cataract surgery.The primary cause of irvine gass syndrome is usually linked to surgical trauma incurred during cataract surgery.This can inadvertently lead to the disruption of the blood-retinal barrier, increasing the permeability of capillaries in the macula, and subsequently causing fluid accumulation.Inflammation plays a crucial role in the development of this syndrome.The surgical trauma triggers an inflammatory response as part of the body's natural healing process.In the case of irvine gass syndrome, pro-inflammatory mediators like cytokines are released, leading to vasodilation and increased vascular permeability in the retina.This, in turn, allows fluid to accumulate in the macular region, causing the characteristic symptoms of the syndrome.Individuals with a history of retinal conditions, uveitis, or diabetic retinopathy may be at higher risk.Surgeries that are complicated or lengthy can cause more trauma to the eye, increasing the risk of developing the syndrome.The use of certain medications, like prostaglandin analogs, may exacerbate the condition.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19770254
• Report Number: 1119421-2024-01343
• Device Sequence Number: 21062989
• Product Code: POE
• UDI-Device Identifier: 00380652421720
• UDI-Public: (01)00380652421720(17)280724(11)230727(10)15687857(21)15687857036
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: DFT315
• Device Lot Number: 15687857
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 07/27/2023
• 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: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female