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

Model Number	SN6AD1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported following an intraocular lens implant procedure, the patient experienced double vision, unhappy with quality of vision and refractive outcome.The lens was later exchanged in a secondary procedure.There was no patient harm and the patient was not hospitalized.Additional information has been requested.
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).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.The lens is cut into two pieces, typical of insertion and removal from the eye.Marks are observed on both pieces of the lens that are in the shape of a surgical instrument used to grasp the lens.A power and resolution inspection could not be conducted due to extensive damage.Product history records were reviewed and the documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The root cause cannot be determined.A power and resolution inspection could not be conducted due to extensive damage.A non health care professional reported explant due to double vision, unhappy with quality of vision and refractive outcome.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15650676
• Report Number: 1119421-2022-02251
• Device Sequence Number: 20324854
• Product Code: MFK
• UDI-Device Identifier: 00380652241724
• UDI-Public: 00380652241724
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2022

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: 02/28/2019
• Device Model Number: SN6AD1
• Device Lot Number: 12281719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2014
• 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: 68 YR
• Patient Sex: Female