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

Model Number	CNA0T0
Medical Device Problem Codes	Defective Component (2292); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, when finger was off at the plunger, yet the thrust continued.The implantation went well during the surgery.Sometimes a slight touch was enough and the thrust continues.The sensitivity of the shooters doesn't seem identical.There was no patient harm reported.Additional information has been created.There are two reports associated with this file.Thus is 1 of 2.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was confirmed.The device was returned in a blister tray inside the carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the tip of the nozzle.Iol was not returned.No damage observed.The lever is moving freely.The device is taken apart for further testing.Mark is observed on valve o-ring closer to the orifice at 12 o'clock position.The root cause is deemed to be manufacturing related (the faulty sub-assembly is supplied by company vendor).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and sated that, the advancement of the iol stops as soon as surgeon release the speed regulator.This was not the case.Although the advancement was stopped, the iol continued to be transported in the injector and thus arrived (uncontrolled) in the eye.The surgeon is very experienced and recognised the danger in time,so there were no complications.The advance of the iol could not be controlled.
Additional Manufacturer Narrative
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: 17225161
• Report Number: 9612169-2023-00489
• Device Sequence Number: 7076138
• Product Code: HQL
• UDI-Device Identifier: 00380652393645
• UDI-Public: 00380652393645
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

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: 03/05/2025
• Device Model Number: CNA0T0
• Device Lot Number: 25366279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: Not provided; 08/21/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/28/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• Patient Sex: Unknown