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

Model Number	SN6AT7
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis, the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens implant procedure, the lens appeared to be rotated by 12 degrees.Additional information was received and reported that the lens was repositioned.

• 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: 12649127
• Report Number: 1119421-2021-01943
• Device Sequence Number: 16500821
• Product Code: MJP
• UDI-Device Identifier: 00380652275804
• UDI-Public: 00380652275804
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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 Model Number: SN6AT7
• Device Catalogue Number: SN6AT7.140
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention