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 Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that after an intraocular lens (iol) implant surgery, a patient experienced poor vision.The surgeon removed the lens on a secondary procedure with the reason of wrong iol power.Additional information has been requested.
Event or Problem Description
Additional information has been requested and received stating the patient is happy now.
Additional Manufacturer Narrative
Additional information provided in a.2., b.3., b.5., b.6., and d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Up on further review it was identified that the patient had an explant due to implantation of wrong iol power.Hence this file is no longer reportable.
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.This report does not meet criteria of serious injury.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
• MDR Report Key: 11806097
• Report Number: 1119421-2021-01004
• Device Sequence Number: 11633321
• Product Code: MJP
• UDI-Device Identifier: 00380652274784
• UDI-Public: 00380652274784
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

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: 06/30/2023
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6U160
• Device Lot Number: 12633143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 06/25/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/01/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTREPID AUTOSERT HP; INTREPID AUTOSERT IOL HP; MONARCH CARTRIDGE D; MONARCH III IOL HP; INTREPID AUTOSERT IOL HP; MONARCH III IOL HP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR