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

Model Number	CNA0T0
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with a description of the syringe does not push the intraocular lens.Additional information has been requested.
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).
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.The device was returned loose inside the carton.Viscoelastic is observed in the device.The lens is present in the lens bay.The lever is moving freely and the plunger is not advancing.The device is taken apart for further evaluation.The canister is fully punctured.Krytox is observed on the canister neck.No damage observed to canister o ring and other internal parts of the device.The device was reloaded and was reactivated with a new canister.The failure mode could not be replicated the device activated with no issues.The root cause for the reported complaint is deemed to be manufacturing related (the faulty sub assembly is supplied by company vendor in bray).The product did not meet specifications.The plunger is not advancing when the lever is pressed.Based on the results from company product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 20117765
• Report Number: 9612169-2024-00846
• Device Sequence Number: 20670123
• Product Code: HQL
• UDI-Device Identifier: 00380652396479
• UDI-Public: (01)00380652396479(17)240606(11)210608(10)25158862(21)25158862066
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2024

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: Other
• Device Expiration Date: 06/06/2024
• Device Model Number: CNA0T0
• Device Lot Number: 25158862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 10/24/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 10/01/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown