MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT5
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation procedure, the surgeon saw three dots on the lens in different locations on one side twice.Additional information was received.The dots were seen as soon as the lens unfolded in the eye.The lens remains implanted.There were no negative consequences for the patient.Patient's refractive outcome was very good.
Additional Manufacturer Narrative
The product was not returned.A photo was provided of a single-piece toric lens implanted in an eye.There appeared to be double toric axis marks on one side of the lens.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported axis mark issue could not be determined.The lens remains implanted.A single photo was provided, which appeared to show an axis mark anomaly.It cannot be determined from the photo if this was an artifact or an axis make issue.Physical examination of the lens would be necessary to confirm if this was an artifact or additional axis marks.An investigation was opened to explore if the reported axis issue occurred during the manufacturing process.The focus of the investigation was regarding the various operations where the reported anomaly may have occurred.These identified operations were wafer molding, wafer assembly, casting/curing, and wafer separation.A systematic review of these operations was performed for potential instances where the anomaly could be created.Several factors were evaluated: issue present on wafer optic pin, issue during wafer molding, improper assembly of wafers, issue during casting/curing, and issue created during pop-off reseating.A root cause analysis was conducted, and a clear root cause was not able to be determined.The operational evaluation provided confidence that the reported axis mark anomaly was not created by any recognizable manufacturing process/operation.The surgeon indicated that patient outcome was ¿very good¿ with no visual issue reported.This may indicate the pictured anomaly was an artifact and not an axis mark issue.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 19114736
• Report Number: 1119421-2024-00724
• Device Sequence Number: 7102444
• Product Code: MJP
• UDI-Device Identifier: 00380652251020
• UDI-Public: 00380652251020
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 08/03/2026
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.215
• Device Lot Number: 15241546
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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: HEALON.; UNSPECIFIED INJECTOR.
• Patient Sex: Unknown