MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T3
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during surgery, reported that while just being inserted, surgeon observed the toric marks (3 dots) apx 30deg off from their normal position at the base of the haptics.Additional information has been 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
The product was not returned.A slit lamp photo was in the file.Only a portion of the lens optic was visible in this photo.Of this visible portion of the optic, three toric axis marks are visible in alignment on the optic.Three additional "dots" are shown on the photo lower than the three axis marks.The lower "dots" are not in perfect alignment.The haptics and the other side of the optic was visible in the photo.Information was provided that the doctor drew the lower dots on the picture where, in the doctor's opinion, the axis marks would normally be located.Not enough of the actual lens was visible in the photo to confirm if the axis marks were misaligned.Additional photos would be needed that show the optic and more of the base of the haptics, or the availability of a sample to evaluate, in order to make a final determination.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.The product investigation could not identify a root cause for the reported complaint.The lens remained in the eye.Based on our observation of the attached photo, the reported complaint cannot be confirmed.Not enough of the lens was shown in order to make a determination regarding the location of the toric marks of the optic.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.The hcp provide information that they are in the process of getting a new slit lamp camera and will provide new photos once it is installed.The hcp indicated the patient has no issues.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that the patient had no symptoms whatsoever and everything was perfect.

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19425157
• Report Number: 1119421-2024-01039
• Device Sequence Number: 7923836
• Product Code: MJP
• UDI-Device Identifier: 00380652409599
• UDI-Public: (01)00380652409599(17)270509(11)230511(10)15640592
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/13/2024

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: CNW0T3
• Device Lot Number: 15640592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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