MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the lens was implanted into patient's eye and noticed that patient had the same weird sheen.Physician just left it and proceeded with the goniotomy.Patient had corneal edema ,so couldn¿t see the iol that well but still could see the sheen.Additional information was requested.There are two medical device reports associated with this complaint.This report is 2 of 2.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned for analysis.No sample was returned for analysis.Complaints have been received describing that lenses were reported by doctors for the presence of a ¿polychromatic sheen¿ visible.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating that glare/tint/haze observed on the iol after implantation in the eye.As it was not clear what this was, due to misunderstanding the initial iol was explanted resulting in increased corneal edema post-operatively.Fortunately, the haze cleared post-operatively without causing any lasting visual symptoms.As per physician, it was speculated that the haze might have been due to the release of argon gas from the device, which pushed the iol.There are two medical device reports associated with this complaint.This report is 2 of 2.

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18433965
• Report Number: 9612169-2024-00015
• Device Sequence Number: 17898456
• Product Code: HQL
• UDI-Device Identifier: 00380652396486
• UDI-Public: 00380652396486
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25656751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 03/07/2024; 04/08/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/06/2024; 04/04/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2023
• 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: PROVISC.
• Patient Sex: Female