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

Model Number	SN6AT6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An operation room director reported following an intraocular lens (iol) implant procedure, the patient was not happy with near vision, would prefer distance.The lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for the explant was refractive target was near but prefer distance.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating patient's symptoms were resolved.There was no patient harm.As per surgeon¿s prognosis patient was very happy at the time of reporting.
Additional Manufacturer Narrative
Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The root cause was determined to be unrelated to the lens.The completed questionnaire indicated that the in the surgeon's opinion, a quality issue with the lens did not cause or contribute to the event.The root cause for the event was listed as "pt.Indecision".The questionnaire explained that the lens was explanted due to patient was unsure of what she wanted after procedure was done after trying to accommodate with this lens, the patient wanted it removed.The questionnaire indicated that the explanted lens was not available for return.Follow up attempts were made for more information.The replacement lens is unknown.The questionnaire indicated that the patient's issues have resolved and the surgeon's prognosis is good and the patient is very happy now.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: 16476175
• Report Number: 1119421-2023-00380
• Device Sequence Number: 3198589
• Product Code: MJP
• UDI-Device Identifier: 00380652274272
• UDI-Public: 00380652274272
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 05/15/2026
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.170
• Device Lot Number: 15201562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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: MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR; ORA SYSTEM; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female