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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 in the reported lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported, after the intraocular lens was implanted there was an unexplained capsule rupture in the upper temporal region.The implant went vertical and the surgeon had to remove it.The physician reported that there was no zonal fragility, initially or after the surgery.Additional information is requested.
Additional Manufacturer Narrative
The previous report submitted for this event contained an error, in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received, the right eye is the involved eye.The intraocular lens insertion into the bag was normal.However, the surgeon reports, that the capsule bag was perfect, before the implant injection.And a tear was noted, just after the implant set up.During rinsing, the viscoelastic the iol toggled and exited the capsular bag, because of the rupture, a vitrectomy was performed.A new iol was implanted in the sulcus.And the patient is being monitored post operatively.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.Cracks are observed on the haptic and optic.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The root cause for the reported events could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11396167
• Report Number: 1119421-2021-00452
• Device Sequence Number: 3286841
• Product Code: MFK
• UDI-Device Identifier: 00380652390545
• UDI-Public: 00380652390545
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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: 05/20/2025
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.210
• Device Lot Number: 15071986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 03/31/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/18/2021; 04/01/2021
• 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: DUOVISC VISCOELASTIC SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR