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

Model Number	SN6AT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for analysis.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 non-healthcare professional reported following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.Patient felt vision was worse than before surgery.Doctor found patient to have residual refractive error with posterior capsular haze.It was reported that iris repair was performed and the lens was explained.The lens was replaced with non-company product.There was no patient harm and patient was not hospitalized as a result of this event.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The lens was retuned in a specimen cup.Solution was dried on the lens.The optic was torn/split/cracked and cut into pieces, typical of insertion and removal.The lens was cleaned with klrp for further evaluation.The lens was allowed to dry and appears clear.Power and resolution testing could not be conducted due to the extensive optic damage.Complaint 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.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the company, 16.5 diopter lens was replaced with a non-company intraocular lens, 16.5 diopter with a higher cylinder power.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: 15485868
• Report Number: 1119421-2022-02059
• Device Sequence Number: 7831557
• Product Code: MJP
• UDI-Device Identifier: 00380652250351
• UDI-Public: 00380652250351
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2022

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: 03/31/2025
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.165
• Device Lot Number: 15059022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 64 KG