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 Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample product 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 are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that approximately two years after an intraocular lens (iol) was implanted, it was exchanged for another lens due to the patient was seeing "rings" around lights.Additional information was requested.
Additional Manufacturer Narrative
Corrected data provided in b.5.And h.6.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Initially dysphotopsia was reported as well.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Evaluation summary: information was provided that indicated the use of a qualified cartridge and viscoelastic with a non-qualified handpiece.The product investigation could not identify a root cause for the reported event.The diopter of the replacement lens was not provided.The explanted lens was not returned to evaluate.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: 11566807
• Report Number: 1119421-2021-00637
• Device Sequence Number: 17178462
• Product Code: MFK
• UDI-Device Identifier: 00380652307727
• UDI-Public: 00380652307727
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2021

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: 09/30/2023
• Device Model Number: SV25T0
• Device Catalogue Number: SV25T0U190
• Device Lot Number: 12661435
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 04/08/2021; 05/17/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 03/30/2021; 04/08/2021; 06/03/2021
• 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: DUOVISC.; MONARCH D CARTRIDGE.; MONARCH II IOL HANDPIECE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR