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

Model Number	CNW0T9
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 an intraocular lens (iol) implant procedure, a scratch from the root of the haptic to the front of the center of the optical section was confirmed after implantation.The surgery was completed without product replacement.The sample is not available for return as it was still implanted in the patient's eye.Additional information has been requested and received that the surgeon suspects both iol and cartridge.No health hazard at this time.
Additional Manufacturer Narrative
Video shows iol(intraocular lens) implantation with company cartridge.Iol and cartridge preparation is not recorded.Iol is advanced at the wound guard, iol position for the advancement appears to be in a correct position.Iol is implanted and a large mark/ line is visible over the iol optic.Based on our observation of the attached video, a large mark/ line is visible over the iol optic.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Lens damage may occur: due to the use of a non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastic leading to underfill, overfill, misfolding , delivery issues and /or damage.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 and cause delivery issues and /or damage.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement and cause delivery issues and / or product damage.Any of the above listed causes alone, or in combination, may create the reported event.Based on the results from the product history record, the products met release criteria.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 ; 8007579780
• MDR Report Key: 14905076
• Report Number: 9612169-2022-00313
• Device Sequence Number: 20093663
• Product Code: MJP
• UDI-Device Identifier: 00380652412483
• UDI-Public: 00380652412483
• 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): 09/27/2022

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: CNW0T9
• Device Lot Number: 21284672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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: INTREPID AUTOSERT IOL HANDPIECE; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC
• Patient Sex: Unknown