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

Model Number	CNA0T0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A theatre manager reported that, during intraocular lens (iol) implant procedure, the lens was explanted due to scratches on the lens.The issue must have occurred when the lens was folding and being implanted.Scratch marks were noticed the when the lens unfolded in the eye.Additional information was requested.
Additional Manufacturer Narrative
The device was returned loose in a plastic bag.The lock-out assembly has been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger is fully advanced outside the tip of the nozzle.The nozzle tip has a heavy stress.Iol is returned outside of the device in a specimen container with an unknown solution.Iol is returned in two(2) segments.Solution is dried on the returned segments.The returned segments are scratched/fractured - rejectable.We are unable to determine the root cause for the reported complaint "lens scratched".Damage was observed to the tip of the nozzle.The observed damage typically occurs if there is a lack of viscoelastic between the lens and the cartridge lumen and/or if the plunger is not positioned correctly at the trailing optic edge for advancement.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the nozzle causing damage.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: 13141207
• Report Number: 9612169-2022-00001
• Device Sequence Number: 16511032
• Product Code: HQL
• UDI-Device Identifier: 00380652393607
• UDI-Public: 00380652393607
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 02/08/2024
• Device Model Number: CNA0T0
• Device Lot Number: 25138560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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
• Patient Sex: Unknown