MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	SN6CWS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Uveitis (2122)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported via chinees health authority that, following the cataract surgery with intraocular lens (iol) implant procedure, the patient was diagnosed with postoperative anterior uveitis.On the first postoperative ward visit, it was found that the patient's cornea had foggy edema, with kp+anterior clearance, cells++, and atrial scintillation++.A small amount of exudate film was visible in the pupil area, and the iol was in place.The patient was advised to administer tobramycin dexamethasone eye drops and bromfenac sodium eye drops every 10 minutes.After anti-inflammatory and anti immune treatment, the inflammatory response subsided.It was reported that the events happened due to patient's own reasons.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Information was provided that after anti-inflammatory and auto-immune treatment, the inflammatory response subsided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 17948949
• Report Number: 1119421-2023-01770
• Device Sequence Number: 6715490
• Product Code: HQL
• UDI-Device Identifier: 00380652249225
• UDI-Public: 00380652249225
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.205
• Device Lot Number: 15386657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Female