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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/03/2021
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 no other complaints in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient had visual disturbances.The patient continued blurred/fluctuating vision and difficulty with glare at night.The patient could not adapt to the lens.The iol was exchanged with an alternate iol approximately 6 months following the initial procedure.There was no patient harm.
Additional Manufacturer Narrative
The explanted lens was not returned.An empty non-company lens case (non company lens diopter) was returned, removed from its pouch inside the opened non- company lens carton.Information was provided that indicated the use of a qualified cartridge and handpiece.Information was provided that indicated the use of two non-qualified viscoelastics.The root cause was determined to be unrelated to the lens.The explanted lens was not returned.A facility reported an explant due to visual disturbances and replaced with monofocal intraocular lens (iol).Surgeon reported iol exchange required due to patient could not properly adapt to the edof (extended depth of focus) lens.The replacement lens was reported to be a non-company monofocal model of the same diopter (non company lens diopter).The empty replacement lens case was returned.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING 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: 13170048
• Report Number: 1119421-2022-00028
• Device Sequence Number: 1956060
• Product Code: POE
• UDI-Device Identifier: 00380652424660
• UDI-Public: 00380652424660
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 09/10/2025
• Device Model Number: DAT015
• Device Lot Number: 15098215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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: AMVISC.; HEALON.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Sex: Unknown