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	Eye Injury (1845)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that during the intraocular lens (iol) implant procedure, the injector does not enter the incision precisely, so the lens came out badly.Then with the other device they enlarged the incision and it was fine.
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
The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in a blister tray inside the carton.The lockout assembly has been removed.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.Iol was not returned.No damage observed.No root cause identified.No damage was observed to the device.The customer indicates enlarging the incision , the complaint may have been related to small incision.Company delivery device nozzles come in two sizes and require two different incision size.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: 16761268
• Report Number: 9612169-2023-00298
• Device Sequence Number: 6105526
• Product Code: HQL
• UDI-Device Identifier: 00380652396479
• UDI-Public: 00380652396479
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 04/13/2025
• Device Model Number: CNA0T0
• Device Lot Number: 25388081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED VISCOELASTIC 1.0.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown