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

Model Number	CNA0T0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported with the description of a cracked intraocular lens (iol).Iol was removed during initial procedure and replaced with other lens.There was no immediate harm.The surgeon¿s prognosis was normal recovery.
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
The product was returned for analysis and the reported complaint could not be observed.Iol was not returned.The device was returned in clear plastic bag.The lock-out assembly has been removed.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.No damage or abnormalities observed.No lens returned.The product investigation could not identify the root cause for the reported complaint "cracked lens".The lens was not returned.Due to this, we are unable to confirm the lens and the haptic position for advancement and determine a root cause and review the reported damage.Based on the results from the 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: 18911431
• Report Number: 9612169-2024-00223
• Device Sequence Number: 17899187
• Product Code: HQL
• UDI-Device Identifier: 00380652396479
• UDI-Public: 00380652396479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: Health Professional
• Device Expiration Date: 08/27/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25708546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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: PROVISC
• Patient Sex: Unknown