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 Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 facility representative reported that 50 days following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens due to a refractive error and not able to see well.
Additional Manufacturer Narrative
Correction: on initial mdr the evaluation result code of 213 was an error.It should have been 3221 on the original mdr (corrected information provided in h6.).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: 12148651
• Report Number: 1119421-2021-01352
• Device Sequence Number: 11966152
• Product Code: MFK
• UDI-Device Identifier: 00380652418638
• UDI-Public: 00380652418638
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 10/31/2024
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.165
• Device Lot Number: 12756635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/26/2021
• 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 ASPHERIC UV ABSORBING SINGLEPIECE IOL; ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Outcome Attributed to Adverse Event: Required Intervention