MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	02/03/2021
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 the documentation indicated the product met release criteria.The root cause has not been identified.No other complaints for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision, glare and halos.The iol was removed in a secondary procedure 98 days following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that the intraocular lens (iol) was replaced with another iol.
Additional Manufacturer Narrative
Information was provided in the file that indicated the use of a qualified company cartridge and company handpiece.The customer indicated the use of a viscoelastic, which is not qualified for company cartridge use.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12372461
• Report Number: 1119421-2021-01641
• Device Sequence Number: 19837310
• Product Code: MFK
• UDI-Device Identifier: 00380652418713
• UDI-Public: 00380652418713
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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: 02/17/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.205
• Device Lot Number: 15038624
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/30/2021; 10/05/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/24/2021; 10/26/2021
• 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: ACRYSOF TORIC SINGLEPIECE IOL; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; NUVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR