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

Model Number	SN6AD1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported following an intraocular lens implant procedure, the patient experienced fading vision possible ugh syndrome/ uveitis-glaucoma-hyphema (ugh) syndrome.The lens was later exchanged in a secondary procedure.Additional information has been requested and received which states right eye vision becomes extremely hazy intermittently.No patient harm noticed.
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).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.10.The lens was returned in a plastic bag on a surgical sponge.Solution was dried on the lens.One haptic was broken (possibly cut) in the gusset area (not returned).The optic is cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Qualified associated products were indicated.The viscoelastic indicated is non-qualified for the lens/injector combination indicated.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided in the file that the multifocal 14.5 diopter lens was exchanged for a non-company monofocal lens.Due to the exchange of a monofocal lens to a multifocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13892708
• Report Number: 1119421-2022-00567
• Device Sequence Number: 13900762
• Product Code: MFK
• UDI-Device Identifier: 00380652241571
• UDI-Public: 00380652241571
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2022

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: 01/31/2019
• Device Model Number: SN6AD1
• Device Lot Number: 12274260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2014
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; OCCUCOAT.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown