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

Model Number	SY60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2024
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).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, it was noted that there was an opacification on the lens surface after implantation.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Only video was returned.Returned photos and video show implanted intraocular lens (iol).There appears to be "polychromatic sheen" effect visible on the implanted iol.The root cause is deemed to be manufacturing related.The cause of ¿sheen¿ or ¿film-like¿ appearance is a result of a change in the positioning of the iol during the manufacturing process and is not associated with any foreign material or contamination.The observation has been reported clinically and confirmed in laboratory settings to rapidly disappear following implantation and should no longer be visible, or very little remaining, by the one-day postoperative visit.The appearance is a result of a temporary change in the surface of the iol that occurs during the delivery process which is only visible under certain orientations and illumination settings.This quickly resolves once the iol is delivered and exposed to intraocular temperature over time.There are no adverse impacts or lasting effects on the iol or the patient, and no adverse events or clinical impact on vision have been reported associated with this finding.Nci was previously raised for this issue.Capas were initiated to address this issue.Product referenced in this complaint has been manufactured prior to the implementation of the capa actions.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: 19517950
• Report Number: 9612169-2024-00550
• Device Sequence Number: 20376111
• Product Code: HQL
• UDI-Device Identifier: 00380652251570
• UDI-Public: (01)00380652251570(17)270311(11)230313(10)25609131(21)25609131176
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 Model Number: SY60WF
• Device Lot Number: 25609131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 03/13/2023
• 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