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

Model Number	CNW0T7
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
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.Additional information was requested, but no further information is available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that a crack about 1mm was found near the optic toric mark after implanting the intraocular lens (iol) with the cartridge.The surgery was completed without product replacement.There was no patient harm reported.The sample is not available as it still remained in patient's eye.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned for analysis, the lens remains implanted.Video was provided.Video provided showing iol implantation.Lens preparation for implantation is not provided.A cartridge comes in the picture with iol advanced at the pause location.The exact lens position for the advancement cannot be confirmed from the video.It appears that ovd fill line is visible up till mid nozzle tip with the lens already at the pause location.This potentially indicates that the ovd might not be filled accurately.As the lens is implanted and begins to unfold, a mark/line is visible over the optic area at around 9 o'clock position over the optic area.A mark/ line was observed over the optic area of the iol.Ovd fill and lens loading was not provided in the video.Ovd fill line was noted to be insufficient in the video, which may have contributed to the reported complaint.However, a definite conclusion cannot be made from the available footage.The instruction for use (ifu) instructs: "completely fill the cartridge with ovd, immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device." if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or cause damage to the product.All product and batch history records are quality reviewed prior to product release.Based on the trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.The manufacturer internal reference number is: (b)(4).

• 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 ; 8175514979
• MDR Report Key: 12307850
• Report Number: 9612169-2021-00166
• Device Sequence Number: 19896603
• Product Code: MJP
• UDI-Device Identifier: 00380652402453
• UDI-Public: 00380652402453
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2021

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: CNW0T7
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Sex: Unknown