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

Model Number	CNW0T5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implantation procedure, trailing haptic broken in eye.The procedure was completed on the same day.Additional information has been requested, yet no new information received.
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 was provided in h.3., h.6.And h.11 the lens was returned positioned incorrectly in the lens case inside the lens carton.Solution was dried on the lens.The optic was cut into two portions, typical of an insertion and removal.One haptic was broken in the gusset area.The broken haptic was returned to the well area of the lens case.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.The root cause cannot be determined for the reported complaint.The lens was returned cut into pieces, typical of an insertion and removal.The reported broken haptic damage was observed.The position of the lens and haptics during delivery cannot be confirmed based on the sample evaluation.The broken haptic was reported as the trailing haptic.It is unknown if the lens was in the correct position for advancement per the ifu (instruction for use).Using holding forceps, grasp the lens by the optic edge and gently place the anterior lens side up into the back of the ovd (ophthalmic visco surgical device)-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly, causing delivery issues and/or damage.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; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 25093752
• Report Number: 1119421-2026-00963
• Device Sequence Number: 5031073
• Product Code: MJP
• UDI-Device Identifier: 00380652410595
• UDI-Public: (01)00380652410595(17)270709(11)230711(10)15675826
• 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): 05/29/2026

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: CNW0T5
• Device Lot Number: 15675826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC OVD.; VISCOAT OVD.
• Patient Age: 83 YR
• Patient Sex: Male