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	Conjunctivitis (1784); Corneal Edema (1791); Inflammation (1932); Iritis (1940); Blurred Vision (2137)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced late onset (toxic anterior segment syndrome) tass, anterior chamber reaction with fibrin, corneal swelling, descemet folds and the fibrin on the capsule edge.The patient is currently under treatment and improving.Additional information was received stating that, as per the surgeon's opinion, the suspected late onset of the toxic anterior segment syndrome (tass) could be related to lens material.The patient also had unspecified complaints of this eye in the days before the event.The patient has been treated with steroid ointment and antibiotics.The physician also stated that, in the left eye the vision went down from 20/25 to 20/40 at the moment and is improving.The patient also had significant edema vision was down to 20/200 in the left eye.The edema developed after 2 or more weeks, 1 week after surgery there was no clinical edema present.There are two medical device reports associated with this patient.This report is associated with the left eye.
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
Correction: on initial mdr the product evaluation code of 4114 was an error.It should have been 4117 on the original mdr.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.It is unknown if a qualified cartridge and handpiece were used with the indicated qualified viscoelastic,.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.All 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.Information was provided that the patient improved with treatment.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: 18308326
• Report Number: 1119421-2023-02135
• Device Sequence Number: 6115259
• Product Code: POE
• UDI-Device Identifier: 00380652421690
• UDI-Public: 00380652421690
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/20/2024

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: 15655270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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: CEFUROXIME; EYEFILL HD; PROVISC; RINGER LACTATE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female