MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure noticed that foggy appearance of intraocular lens when implanted in the eye, it takes several minutes for the foggy appearance to resolve, due to that surgeon had difficulty centering lens.There are two medical reports associated with this patient.This file belongs to right eye.Additional information was requested.
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
Additional information has been provided in d.1., d.2., h.3., h.6., and h.11 correction information - the serial number (b)(6) provided in the mfg report number (9612169-2024-00704) was an error, the serial number is pertaining to the mfg report number of 9612169-2024-00695.The mfg report¿s serial number is unknown.The product was not returned for analysis.No sample was returned for analysis.The reported complaint cannot be confirmed based on the available information.Complaints have been received describing that lenses were reported by doctors for the presence of a polychromatic sheen visible.An nci was initiated for this issue.The cause of sheen or film-like appearance is a result of a change in the positioning of the intraocular lens (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.No reports of impact to visual function in any of the complaints reported.All product history records are quality reviewed prior to product release.The manufacturer internal reference number is:(b)(4).

• Brand Name: CLAREON IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 19759207
• Report Number: 9612169-2024-00704
• Device Sequence Number: 8850260
• Product Code: MFK
• UDI-Device Identifier: 00380652405287
• UDI-Public: 00380652405287
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: CNWET0
• Device Catalogue Number: CNWET0.220
• Device Lot Number: 25733988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/07/2024
• Date Device Manufactured: 10/18/2023
• 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: Female