MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
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 nurse reported that during the cataract surgery with intraocular lens (iol), implant procedure, when inserting the lens, a white substance was observed on one of the haptic parts.The procedure was completed with anew product and there was no adverse event to the patient.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was not observed.Iol returned in three segments in intraocular lens (iol) case.A part of the iol including one haptic was not returned.Solution is dried on the segments.The reported "white substance" was not observed on the returned haptic.No root cause identified as the reported complaint " white substance was observed on one of the haptic parts" was not observed.Only one haptic was returned with the iol.The reported complaint was not observed on the returned haptic.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
• 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: 17031532
• Report Number: 9612169-2023-00412
• Device Sequence Number: 6459990
• Product Code: HQL
• UDI-Device Identifier: 00380652251334
• UDI-Public: 00380652251334
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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: 11/17/2024
• Device Model Number: SY60WF
• Device Lot Number: 25226893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2021
• 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