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

Model Number	SN6AD1
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Inflammation (1932); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that, after intraocular lens implantation surgery, the patient experienced blurriness to one eye.The examination shows, a superficial, swirling, very thin layer of something opaque on the lens.The patient also have advanced renal cancer and is on chemo.Pred and prolensa seem to have no effect.So the physician doubt it to be inflammatory.Additional information was received stating that, the patient had developed milky swirling superficial deposition of some sort.A yag surgery was performed and nothing worked.The doctor is trying restasis now.The doctor doubts that if it is related to any material issue, the nature is of a deposition of something.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A director of gqqa discussed the case and the provided photo with the surgeon.¿appears to have a fibrinous appearance, but the picture quality was not high enough to discern much.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the lens was implanted placed (b)(6) 2014.A director of gqqa discussed the case and provided photo with the surgeon.No determination could be made from the photo.It was recommended to contact expert opinion md.Surgeon did not feel that would be beneficial 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: 17331477
• Report Number: 1119421-2023-01258
• Device Sequence Number: 7361319
• Product Code: MFK
• UDI-Device Identifier: 00380652241601
• UDI-Public: 00380652241601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: SN6AD1
• Device Lot Number: 12281676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male