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

Model Number	CNW0T4
Medical Device Problem Codes	Dent in Material (2526); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
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 non-health care professional reported that during an intraocular lens (iol) implant procedure observed cracked lens.Additional information was requested and received stated there was a notch taken off the lens edge near the haptic.There was no patient harm.
Event or Problem Description
Additional information was requested and received stated there was a loading error.
Additional Manufacturer Narrative
The lens was returned with lens case lid component inside a self sealed non-company pouch placed inside the lens carton.Viscoelastic was dried on the lens.The optic has a line of cracked damage and scratched near the optic edge.This was most likely interpreted as the complaint.A photo was available in the file of what appeared to be two lenses located in the eye, prior to removal.One lens appeared to be damaged on the edge, on the optic surface and one haptic appeared broken.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge, handpiece, and viscoelastic were indicated.Based on information provided that the complaint was due to a loading error, this reasonably suggests that the complaint is unrelated to a product malfunction.Information was provided from the sr.Cataract account manager stating, " the customer and i have determined it was a loading error so you can close the case." the customer's specific loading error was not stated.Lens damage was observed to the returned lens identified for this file.The optic damage may have been interpreted as the reported complaint.A photo was also provided that displayed what appeared to be two lenses in the eye, with damage to one lens observed.It is unknown if the presence of the second lens was due to a surgeon selected piggyback style method or a non-recommended method of implantation per the ifu (instructions for use).Follow up was attempted regarding the photo, and no response has been provided to date.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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: 19850866
• Report Number: 1119421-2024-01422
• Device Sequence Number: 6482511
• Product Code: MJP
• UDI-Device Identifier: 00380652402347
• UDI-Public: (01)00380652402347(17)270807(11)230809(10)15690943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: CNW0T4
• Device Lot Number: 15690943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/25/2024
• Date Device Manufactured: 08/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE D; MONARCH III INJECTOR; PROVISC
• Patient Age: 84 YR
• Patient Sex: Female