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

Model Number	SN6AT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 facility representative reported an explantation of an intraocular lens (iol) with a clinical reason for explant of "wrong power." additional information was received indicating "wrong power with rotation missed aim." additional clarification has been requested; however, further information has not been received.
Additional Manufacturer Narrative
Additional information was provided in b.5.And h.10.The initial decision to report was incorrect resulting in the initial report being submitted in error.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The 21.0 lens was exchanged for a 21.5 lens 21.0 lens due to wrong power, rotation issue and missed aim.This does not meet criteria for reporting based on applicable medical device regulations.A lens exchange from one power to a different power is an attempt to adjust or fine tune the refractive outcome trying to achieve a desired target when the initial lens calculations did not achieve the intended outcome.There is no reported defect or fault with the lens.

• 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: 11753807
• Report Number: 1119421-2021-00936
• Device Sequence Number: 4138717
• Product Code: MJP
• UDI-Device Identifier: 00380652249911
• UDI-Public: 00380652249911
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2025
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.210
• Device Lot Number: 15027155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR; PROVISC; MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR