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

Model Number	CNA0T0
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	Insufficient Information (4580)
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 nurse reported that, during intraocular lens implantation surgery, the lens appeared to have foggy and hazy film appearance.Additional information was requested but no further information received.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was not observed.The intraocular lens (iol) was damaged and this damage was not mentioned by the customer.The device was returned loose in 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.No damage observed.The lens is returned outside of the device, adhered to the adm lever.Iol is returned in two segments.Significant amount of solution is dried on the lens.One haptic is broken/torn and not returned.The optic is cracked/fractured and scratched/marked - rejectable.The reported "foggy and hazy film appearance" event cannot be confirmed due to the condition of the returned iol.No root cause identified as the reported complaint " foggy and hazy film appearance" could not be confirmed due to the condition of the returned iol.The returned iol shows evidence of handling by the customer as the plunger has been fully advanced outside the tip of the nozzle and significant amount of solution is dried on the lens.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Complaints have been received describing that lenses were reported by doctors for the presence of a ¿polychromatic sheen¿ visible.No harm to patients reported.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: 17115970
• Report Number: 9612169-2023-00445
• Device Sequence Number: 7154300
• Product Code: HQL
• UDI-Device Identifier: 00380652393812
• UDI-Public: 00380652393812
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2024

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: 02/14/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25595003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 03/05/2024
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/26/2023; 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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
• Patient Sex: Unknown