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

Model Number	DFT015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the legs of the lens were broken.There was no patient contact and no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3.,h.6 and h.11.The lens was returned positioned incorrectly in the lens case in the lens carton.One haptic was broken at a post of the lens case.An indentation into the top of the material of the lens case post was observed.The broken haptic was returned outside the well area of the lens case.The optic was pressed against a post of the lens case near the second haptic/optic junction.The second haptic was pressed and broken against this post of the lens case.The broken haptic was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The lens was damaged and an indentation was observed on the top of a post of the lens case.This would indicate that the haptic had become misaligned in the lens case and was pressed down onto the top of the post.Due to the absence of clinical solution on the returned sample the root cause is potentially manufacturing related.If the lens becomes misaligned in the lens case, lens damage may occur.Once a product leaves the manufacturing site, mishandling or accidental downward pressure applied to the carton's exterior could impact the product during transport or during shipment.If accidental mishandling occurs beyond manufacturing during shipping of the product, including placing external force onto one side of lens carton, this can result in a pinching of one side of the lens case.This shipping mishandling can create a stretch to the locking arm of the lens case, allowing a temporary gap.The gap may allow the lens to shift inside the lens case.The lens will then be misaligned inside the lens case which can cause damage upon release of the externally applied pressure.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; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22194986
• Report Number: 1119421-2025-01644
• Device Sequence Number: 18452632
• Product Code: POE
• UDI-Device Identifier: 00380652421263
• UDI-Public: (01)00380652421263(17)290407(11)240409(10)15838928
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFT015
• Device Catalogue Number: DFT015.215
• Device Lot Number: 15838928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Patient Sex: Unknown