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

Model Number	CCW0T4
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during a cataract removal and intraocular lens (iol) implant procedure in patient's left eye, when the iol was being loaded the surgeon noticed that the trailing haptic came unfolded with confirmed no patient contact and surgeon elected to open a new lens.Incision was not enlarged.It was unknown procedure was completed on same day.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d3., d.9., e.1., g.1., h.3., h.6.And h.11.The lens was returned advanced to the nozzle entry in a company iii (d) cartridge.Viscoelastic was observed.The trailing haptic was not tucked per the instructions for use (ifu).The leading haptic was tucked in the optic fold.The cartridge had evidence of placement into a handpiece.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated.The handpiece model and viscoelastic was used were not provide.It is unknown if qualified products were used.The root cause for the unfold trailing haptic appears to be related to a failure to follow the ifu.Trailing haptic placement is manual step conducted by the end user.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ophthalmic viscosurgical device (ovd)-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.It is unknown if a qualified viscoelastic was used.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC UV ABSORBING 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: 21035640
• Report Number: 1119421-2024-02646
• Device Sequence Number: 7655958
• Product Code: MJP
• UDI-Device Identifier: 00380652432856
• UDI-Public: (01)00380652432856(17)260912(11)220914(10)15491922
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: 09/12/2026
• Device Model Number: CCW0T4
• Device Lot Number: 15491922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/28/2025
• Date Device Manufactured: 09/14/2022
• 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 IOL INJECTOR, UNSPECIFIED
• Patient Age: 80 YR
• Patient Sex: Male