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 Code	Blurred Vision (2137)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the patient experienced blurred vision.The iol was exchanged in a secondary procedure.The clinical reason for explant was mechanical complication.Additional information has been requested.
Additional Manufacturer Narrative
The iol (intraocular lens) was returned on a piece of white medical sponge placed into a plastic specimen cup.Viscoelastic was observed on the lens.One haptic distal area was nicked on the anterior surface.The power, cylinder, and resolution was re-checked by engineering tech, r.Fannin.The results show that the lens met specification for an suspect (1.50cyl), 14.5 diopter lens.Product history records were reviewed and documentation indicated the product met release criteria.The account indicated the use of qualified cartridge and handpiece.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint of "explant blurred vision".The initial report description indicated that a facility representative reported an explanted iol with patient reason blurred vision.Clinical reason was mechanical complication.The iol does not have a mechanical component--the terminology used to report mechanical complication is an insurance coding term that is used for billing and coding when a lens is exchanged---the verbiage does not indicate a lens malfunction.Each lens is subjected to a 100% assessment of the power, cylinder, and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company suspect monofocal (1.50cyl), 14.5 diopter lens was replaced with a company's trifocal (1.50cyl), 14.5 diopter (add power +2.2/+3.2) lens.Due to the exchange of a monofocal lens to a multifocal lens of the same diopter, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.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: 17286483
• Report Number: 1119421-2023-01229
• Device Sequence Number: 6176566
• Product Code: HQL
• UDI-Device Identifier: 00380652335652
• UDI-Public: 00380652335652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 02/28/2026
• Device Model Number: SA6AT3
• Device Lot Number: 15152590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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: BARRETT; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female