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

Model Number	DAT015
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, the lens was explanted in a secondary procedure after 6 week of initial implantation.The lens was replaced with non company subluxed lens.Additional information was received stating there was no patient harm during the surgery.
Additional Manufacturer Narrative
Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.A small crack is observed on the edge of the optic.All product and batch history records are quality reviewed prior to product release.There are no other complaints in this lot.The file indicates the use of a qualified cartridge and handpiece.The file indicates the use of a non-qualified viscoelastic.Lens damage was observed.The product investigation could not identify a root cause for the reported event.Information was received stating the reason for explant was a subluxed lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating there was no patient harm during the surgery and physician reason for explant was dislocated lens.

• 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: 15876677
• Report Number: 1119421-2022-02512
• Device Sequence Number: 5398407
• Product Code: POE
• UDI-Device Identifier: 00380652424554
• UDI-Public: 00380652424554
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2022

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 Model Number: DAT015
• Device Lot Number: 15368879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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 PLUS; MONARCH II INJECTOR; MONARCH III CARTRIDGE C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female