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

Model Number	TFNT00
Medical Device Problem Codes	Material Opacification (1426); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A doctor reported that after the initial intraocular lens (iol) implant procedure, he noticed film on the iol, deposits on the surface of the lens like glistening, and the patient complained of "blurry vision".This required the removal of the iol in a secondary surgery.There was no reported patient impact.
Event or Problem Description
Additional information received from patient stating that her vision was impaired, she had unexpected post-op visual problems and pain and that the disparities with her vision gave her headaches.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Product evaluation: the lens was returned cut into two pieces inside a self-seal pouch.Viscoelastic and a small amount of blood are observed.The lens appears clear, other than the surface solutions.The smaller portion was sent to the local particle lab.The larger portion was placed into a lens case and retained.Local particle lab: the lens was visually and microscopically examined.Microscopic examination showed an opaque residue approximately 3.5mm in length adhered to the lens.The opaque residue was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the opaque residues generated spectra to a library of spectra found the best match to be viscoelastic.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.The root cause for the reported complaint could not be determined.If new information is provided the file will be reopened.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
In smdr mfg num 1119421-2021-00784, follow up 1, there was no new information in d6.The new information was in h6.The manufacturer internal reference number is:(b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11641911
• Report Number: 1119421-2021-00784
• Device Sequence Number: 3124535
• Product Code: MFK
• UDI-Device Identifier: 00380652414951
• UDI-Public: 00380652414951
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2021

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: 06/10/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U180
• Device Lot Number: 15074645
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 05/04/2021; 08/06/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/04/2021; 05/26/2021; 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention