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

Model Number	CCWTT5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implantation procedure, the doctor noticed a crack in lens.The lens was taken out and the procedure was completed with a different lens during initial procedure without harm to the patient.Additional information was requested, but no further information is available.
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 lens was returned positioned incorrectly in the lens case inside the lens carton.Viscoelastic and what appears to be blood was dried on the lens.The optic has a line of cracked damage near the edge.A large portion of the optic was broken near the cracked damage.The broken optic portion included the second haptic.The broken optic and second haptic were not returned.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The reported "crack in lens" was observed.Additional broken optic damage was also observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, and the review of manufacturing records, 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.Follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.During lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING 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: 18595462
• Report Number: 1119421-2024-00152
• Device Sequence Number: 6857481
• Product Code: MJP
• UDI-Device Identifier: 00380652458351
• UDI-Public: 00380652458351
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 01/14/2025
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.155
• Device Lot Number: 15252014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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: FOLDING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED REPLACEMENT LENS
• Patient Age: 75 YR
• Patient Sex: Female