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

Model Number	TFNT40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported with a description of glistening found on intraocular lens (iol).Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The product was not returned.Photos were available in the file and reviewed by a member of gqca.Only photos were available to evaluate.The root cause cannot be determined for the reported complaint of glistenings.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.A clinical photo analysis was requested from hwv to gqca (global quality customer affairs).A director with the gqca group provided a clinical review.Clinical information review - photograph analysis was conducted by a director with company gqca (global quality customer affairs) group.Photos of the bilateral files were conducted.The findings from the review of the attached photos were: findings it is unknown which eye this photograph represents.Specific to the reported event: an apparent multifocal iol appears well centered behind the pupil opening.Multiple, small, diffuse pinpoint opacities are visible within the pupil space.As the photograph is a dimensional image, the exact location, whether anterior, within, and/or immediately posterior to th cannot be determined.Notifeye attachment 1_22 sep 2023.Jpg and notifeye attachment 2_22 sep 2023.Jpg both images represent the left eye based on descriptive information captured in the photograph.Specific to the reported event there are no apparent findings representing the typical signs glistenings.Conclusion glistenings, described as small, circular or oval-shaped fluid-filled spaces within an iol, appear as tiny, reflective, bubble-like formations under specific lighting conditions.Based solely on the analysis of three photographs, confirming the appearance of glistenings is inconclusive.However, the findings in photograph 1 are likely to represent glistenings if located within the iol.Photographs 2 and 3 do not exhibit typical glistening characteristics.Any differences between the three photos, if the same eye is represented, are probably due to variations in photographic conditions.Suggestions were made from gqca to the customer in the clinical information photo analysis in regards to photographs in order to help enhance the photographic analysis of the reported event.This comprehensive approach would facilitate a more thorough and accurate photographic analysis.Multiple follow ups were made for clarifications and more information.The surgeon indicated to the account representative that regarding the od and os, the surgeon is not changing od and os settings in his slit lamp, so he cannot provide the details which is left or right eye.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: 17938690
• Report Number: 1119421-2023-01755
• Device Sequence Number: 15121195
• Product Code: MFK
• UDI-Device Identifier: 00380652390767
• UDI-Public: 00380652390767
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.340
• Device Lot Number: 12682009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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
• Patient Age: 23 YR
• Patient Sex: Female