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

Model Number	CNW0T6
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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.  there have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An ophthalmic surgeon reported that during implantation of an intraocular lens (iol) the optic cracked.The surgery was completed without product replacement.The sample is not available as it still remains in the patient's eye.In surgeons opinion in the video the crack seemed like lubricant of the cartridge.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Video was provided and the reported complaint was observed.Video on the lens preparation is not provided.When the cartridge comes in the picture, the lens is advanced at the pause location.The lens appears to be in an acceptable position for implantation.Once the lens is implanted and begins to unfold - a large, deep scratch/ crack/ mark is visible over the left side of the optic area.The complainant states the use of non-company as viscoelastic which is not qualified to be used with the associated iol(intraocular lens) model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow ifu(instructions for use), as the customer states the use of non-qualified viscoelastic.The use of an unqualified ovd(ophthalmic viscosurgical devices) may cause damage to the lens and potential complications during the implantation process.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating that in surgeons opinion there was a possibility that coating material of the cartridge was adhered on the lens.

• Brand Name: CLAREON TORIC 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: 13513485
• Report Number: 9612169-2022-00063
• Device Sequence Number: 5299743
• Product Code: MJP
• UDI-Device Identifier: 00380652411219
• UDI-Public: 00380652411219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 01/31/2024
• Device Model Number: CNW0T6
• Device Lot Number: 21283902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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: CLAREON MONARCH IV IOL INJECTOR; MONARCH III IOL CARTRIDGE D; OPEGAN-HI
• Patient Sex: Unknown