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

Model Number	SY60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A physician reported that during surgery, three lenses were scratched.It was noticed during implantation of the lens and one of the lens had to be explanted.There was patient contact however no patient harm.Sample has been discarded.Additional information has been requested.There are two medical reports associated with this patient.This file belongs to the left eye.
Additional Manufacturer Narrative
Correction information has been provided in d.4.Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis the root cause for the reported complaint could not be determined as no sample was returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: 2024-47089 h.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19725668
• Report Number: 9612169-2024-00685
• Device Sequence Number: 18215299
• Product Code: HQL
• UDI-Device Identifier: 00380652251617
• UDI-Public: (01)00380652251617(17)250312(11)211019(10)25290797(21)25290797091
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 03/12/2025
• Device Model Number: SY60WF
• Device Lot Number: 25290797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 10/19/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 69 YR
• Patient Sex: Male