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

Model Number	TFAT40
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported an explant has been planned due to no longer can see clear out of os, feels always blurry and not clear.The lens was off positioned and shifted upwards, therefore to attain the correct vision the lens was altered with more astigmatism then wanted at a +1.50.Additional information has been requested.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in a.2., a.3., b.3., b.5., b.6., b.7., d.10 and h.3.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received which states a planned explant has been scheduled on (b)(6) 2022 with the same lens diopter.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received which states that the patient only needed a repositioning of the iol, not an explant.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge was used.The associated handpiece and viscoelastic information was not provided.It is unknown if a qualified handpiece and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.The lens was repositioned.No further information has been provided.If additional information were to become available, the file will be reopened and updated.There are no other complaints in this lot.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.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
• 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: 14538688
• Report Number: 1119421-2022-01153
• Device Sequence Number: 20209473
• Product Code: MFK
• UDI-Device Identifier: 00380652419208
• UDI-Public: 00380652419208
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/24/2022

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: 05/31/2024
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.185
• Device Lot Number: 12720802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 06/28/2022; 07/31/2022
• Initial Report FDA Received Date: 05/29/2022
• Supplement Report FDA Received Date: 06/23/2022; 07/22/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male