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

Model Number	DAT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.There were no other complaints reported in the lot number.Root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that following implantation of an intraocular lens (iol) patient experienced bad visual acuity, quality of vision was filmy and results were more myopic than target.Lens was exchanged with a different lens in a secondary procedure.Additional information was received reporting in the surgeon¿s opinion, the product contribute to the event.

• 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
• MDR Report Key: 11789503
• Report Number: 1119421-2021-00973
• Device Sequence Number: 14498300
• Product Code: POE
• UDI-Device Identifier: 00380652426992
• UDI-Public: 00380652426992
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 11/02/2025
• Device Model Number: DAT315
• Device Lot Number: 15110799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: J&J TECNIS TORIC, ZCU150, +14.5, SN (B)(4). ; OVD:HEALON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR