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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.There have been one other complaint for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported that following an cataract surgery with intraocular lens (iol) implant procedure, the patient was unhappy with outcome due to residual cylindrical astigmatism, glare and halos.The iol was exchanged with an alternate monofocal iol 217 days following the initial procedure.No further information is expected.
Additional Manufacturer Narrative
Correction g.3: supplemental medical device report (smdr) #02 manufacturing report number 1119421-2021-02389 is being filed to correct the g.3 date on the supplemental report, filed earlier.Incorrect date of 11-19-2021 is being corrected to 01-22--2022.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
There are two medical device reports associated with this event.This report is associated with the left eye.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The explanted lens was not returned to be evaluated.The file indicated that the multifocal company 20.5 d lens was removed and replaced with a monofocal model company 21.0 diopter lens.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
• 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 ; 8007579780
• MDR Report Key: 13009589
• Report Number: 1119421-2021-02389
• Device Sequence Number: 17503228
• Product Code: MFK
• UDI-Device Identifier: 00380652415538
• UDI-Public: 00380652415538
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2022

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: 04/23/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U205
• Device Lot Number: 15068279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 03/02/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/15/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• 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: BESIVANCE; INVELTYS; KETOROLAC; MESALAMINE; PRAVASTATIN SODIUM; XYLOCAIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female