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

Model Number	SV25T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.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 post implantation of an intraocular lens (iol) the patient experienced vision issues.Post implantation of approximately two years the lens was explanted with another monofocal lens.Additional information was requested.
Event or Problem Description
Additional information was received.And stated that, the patient also had halos.There are two medical device reports associated with this patient.This report is for right eye.
Additional Manufacturer Narrative
Correction: on initial mdr, the evaluation method code of 3331 was missed to report.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: 11929482
• Report Number: 1119421-2021-01155
• Device Sequence Number: 14542104
• Product Code: MFK
• UDI-Device Identifier: 00380652307741
• UDI-Public: 00380652307741
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 10/31/2022
• Device Model Number: SV25T0
• Device Catalogue Number: SV25T0U200
• Device Lot Number: 12581733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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