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

Model Number	SA6AT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the patient unhappy with distance and near vision.The had a hyperopic outcome and needs toric correction.The iol was exchanged in a secondary procedure.There was no patient harm and patient's issues has been resolved.The surgeon¿s prognosis was excellent.
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Solution was dried on the lens.The lens was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.Information was provided in the file that the monofocal toric company (1.50cyl), 21.0 diopter lens model was replaced with a non-company multifocal toric (+23.0 se 1.50d cyl).An intraocular lens exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.Due to the exchange of a monofocal lens to a multifocal lens 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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING 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: 16493729
• Report Number: 1119421-2023-00393
• Device Sequence Number: 6366753
• Product Code: HQL
• UDI-Device Identifier: 00380652335782
• UDI-Public: 00380652335782
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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 Model Number: SA6AT3
• Device Lot Number: 15378030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male