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 Code	Visual Disturbances (2140)
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 reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following a cataract extraction with an intraocular lens (iol) implant procedure, the patient experienced light spreads sharply when looking at the light at night.Even after 5 months postoperatively, the patient continued to complain of the symptoms so that the iol exchange procedure was carried out.Additional information was received stating the patient symptoms resolved.
Additional Manufacturer Narrative
The lens was returned in a plastic specimen cup, wrapped in wet surgical gauzes.The lens was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the toric (1.50cyl) 18.5 diopter, (1.5 extended depth of focus) lens was exchange for a non-company monofocal lens (19.0d).Due to the exchange of a toric extended depth of focus lens to a monofocal lens may have been an improved choice for the patient's vision needs.No additional information has been provided at this time.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: 15222744
• Report Number: 1119421-2022-01769
• Device Sequence Number: 5745938
• Product Code: POE
• UDI-Device Identifier: 00380652421614
• UDI-Public: 00380652421614
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 04/28/2026
• Device Model Number: DFT315
• Device Lot Number: 15195896
• 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: 07/17/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/14/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male