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

Model Number	DAT615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/21/2021
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 reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health professional reported that following cataract surgery the patient experienced near vison is not functional, even treated for fuchs syndrome and also no chance of reading that menu in a restaurant.Additional information was requested and received.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received the reporter indicted that they had no vision right after surgery, but it started to return two days later.Gradually they adjusted to the new lens, and distance vision got better.Reporter was cleared to drive without glasses.
Event or Problem Description
Additional information was received stating the lens was explanted in a secondary procedure.
Additional Manufacturer Narrative
The health care professional provided information that the event was related to a calculation error with a hyperopic surprise.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.The company lens of 12.0 diopter was exchanged for a company lens of 14.5 diopters.A difference of 2.5 diopters and a change in the cylinder power would indicate the event was unrelated to the product.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b5 and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from the consumer stating all the issues in the left eye were resolved and with the left eye doing all the work.There was no corneal transplant in the left eye.There are two medical device reports associated with this patient.This report is associated with the left eye.

• Brand Name: ACRYSOF IQ VIVITY TORIC 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: 15797832
• Report Number: 1119421-2022-02417
• Device Sequence Number: 4790537
• Product Code: POE
• UDI-Device Identifier: 00380652426114
• UDI-Public: 00380652426114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2024

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: 03/22/2026
• Device Model Number: DAT615
• Device Lot Number: 15175510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 03/06/2023; 05/09/2024
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/20/2023; 04/03/2023; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LENSX LASER SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male