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

Model Number	DFT015
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported following an intraocular lens (iol) implant procedure, the intraocular lens had to be removed due to dislocation within the capsule and a slight residual defect.The lens was explanted and replaced with company lens in a secondary procedure.Additional information was requested.
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
The lens was returned in a vial of liquid.The lens was removed for evaluation.One haptic was broken or cut (returned).The optic was cut into two pieces across the center.The power and resolution could not be re-verified due to the optic damage.Associated products were not provided.It is unknown if qualified associated products were used.The root cause for the reported lens dislocated and slight residual refraction could not be determined.No reason was provided by the hcp for the dislocation.The power and resolution could not be re-verified due to the optic damage.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company lens, 16.0 diopter lens was exchange for a company lens, 15.5 diopter lens.This may indicate the replacement lens was an improved choice for the patient's visual needs.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; 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: 18038806
• Report Number: 1119421-2023-01848
• Device Sequence Number: 7480870
• Product Code: POE
• UDI-Device Identifier: 00380652421157
• UDI-Public: 00380652421157
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: DFT015
• Device Lot Number: 12754928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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 EXTENDED VISION IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male