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

Model Number	SN6AD1
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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 approximately 8 years following an intraocular lens (iol) implant procedure, the iol became subluxated.There was no injury to the patient.Additional information was provided by a nurse that the iol was exchanged by flanged intrascleral haptic fixation along with an anterior vitrectomy during a secondary procedure.The patient is healing well with no complications.
Additional Manufacturer Narrative
Product evaluation: the lens was returned for evaluation.The lens is submerged in a clear liquid.The lens has been cut in half, typical of insertion and removal from the eye.A chip is observed on the edge of the optic with missing lens material.A scratch is observed on the optic leading from the nicked area across the optic.Associated products were not provided.It is unknown if qualified products were used.A malfunction has not been indicated or information provided that the lens was the cause of the event.Information was provided that the company 15.5 diopter lens was replaced with a non-company lens.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
• MDR Report Key: 12358632
• Report Number: 1119421-2021-01614
• Device Sequence Number: 14408362
• Product Code: MFK
• UDI-Device Identifier: 00380652241595
• UDI-Public: 00380652241595
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 11/30/2016
• Device Model Number: SN6AD1
• Device Lot Number: 12106801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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
• Patient Age: 82 YR