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	Optical Decentration (1360)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2021
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 physician reported that following an intraocular lens (iol) implant procedure, the patient had reduction of best corrected acuity and complaints of distortion.The patient had mildly decentered iol.Capsulorhexis was small and showed early fibrosis (1+ pco) and a mildly asymmetric phimotic healing pattern.Additional information was requested, received and reported that the patient had lens repositioning.
Additional Manufacturer Narrative
The listed associated products are qualified for use with this lens.The manufacturer internal reference number is: (b)(4).

• 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 ; 8175514979
• MDR Report Key: 12559177
• Report Number: 1119421-2021-01871
• Device Sequence Number: 1295917
• Product Code: POE
• UDI-Device Identifier: 00380652427142
• UDI-Public: 00380652427142
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2025
• Device Model Number: DAT315
• Device Lot Number: 15082283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female