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

Model Number	CNA0T0
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during implantation of an intraocular lens (iol) a plastic filament came out together with the lens, it could be removed in time so it was not placed inside of the capsular bag.Additional information was requested.
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction: on initial mdr the device code of 2969 was an error.It should have been 2944 on the original mdr.The sample was returned for analysis and the reported complaint could not be confirmed.Plastic container returned.Multiple fiber/ particulate type materials observed in the tub.No determination can be made which item was related to the reported complaint.We are unable to determine the root cause for the reported complaint "plastic fiber during iol delivery".Multiple fiber/ particulate type materials observed in the returned container.No determination can be made which item was related to the reported complaint.Based on these investigation findings, we are unable to verify if the product contributed to the event.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: 15794922
• Report Number: 9612169-2022-00614
• Device Sequence Number: 11950694
• Product Code: HQL
• UDI-Device Identifier: 00380652396530
• UDI-Public: 00380652396530
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 02/23/2024
• Device Model Number: CNA0T0
• Device Lot Number: 25156364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/08/2023
• Date Device Manufactured: 02/24/2021
• 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: CLAREON IOL WITH THE AUTONOME DS; PROVISC
• Patient Sex: Unknown