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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Halo (2227)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.All product and batch history records are quality reviewed prior to product release.The product investigation could not identify a root cause for the reported complaint.The multifocal lens of 14.0 diopter (add power +2.2/+3.2) lens was replaced with a non-company monofocal lens model.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had experienced night vision glare, very bothered by halos.The iol was exchanged for another lens (date unknown) following the initial implant procedure.The clinical reason given for the explant was ¿patient very unhappy with lens - issues with glare at night & halos".Additional information was requested.

• 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: 12281390
• Report Number: 1119421-2021-01523
• Device Sequence Number: 17095747
• Product Code: MFK
• UDI-Device Identifier: 00380652414876
• UDI-Public: 00380652414876
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 07/07/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U140
• Device Lot Number: 15080629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/05/2021
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; REPLACEMENT IOL:TECHNIS Z9002SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR