MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT4
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Intraocular lens (iol) returned in two segments in an opened non-company blister tray.Solution is dried on the iol.Both haptics are intact.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.A used company cartridge was returned.Viscoelastic was observed in the cartridge.Heavy tip stress was observed.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The heavy stress may indicate the lens/plunger were not in an acceptable position for advancement.The root cause for the reported complaint appears to be related to a failure to follow the instructions for use (ifu).The heavy stress may indicate the lens/plunger were not in acceptable positions.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.Based on the results from the product history record, the products met release criteria.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported with a description of doctor saw a scratch in the lens when he looked at it under the microscope.It was not implanted.The procedure was completed with another lens.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20798821
• Report Number: 9612169-2024-01226
• Device Sequence Number: 15144697
• Product Code: MJP
• UDI-Device Identifier: 00380652469104
• UDI-Public: (01)00380652469104(17)260309(11)220311(10)25370638
• 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
• Report Date (Section B): 11/27/2024

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: 03/09/2026
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.220
• Device Lot Number: 25370638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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: MCPHERSON FORCEPS.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown