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

Model Number	CNW0T5
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported after an iol was implanted, two line-like foreign materials were found on the back of the iol.When aspirated them by irrigation and aspiration (ia), one was removed, but the other was not.The surgery was completed without product replacement.The patient after surgery had no problems, including the va.Additional information has been requested and received which states the two line could also be referred to scratch.
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).
Additional Manufacturer Narrative
Video was provided confirming reported complaint.Video review: video shows iol(intraocular lens) implantation with company cartridge.Iol and cartridge preparation is not recorded.Iol is advanced at the depth guard, the position of the iol for the advancement cannot be confirmed, it appears to be acceptable.Iol is implanted and 2 lines/ marks are visible over the iol optic.One of the marks can be confirmed to be a foreign material on the posterior surface of the iol as the hcp(healthcare professional) is performing removal of the observed particulate, successfully removed.No confirmation can be made if the second mark is a scratch or a foreign material, hcp completes the surgery with mark/ line remaining over the iol optic.The complainant indicates the use of non company viscoelastic, which is not qualified to be used with associated company iol model.Based on our observation of the attached video, marks/ lines are observed over the iol optic post implantation.It is confirmed that one of the marks is foreign material which is removed during the surgery.The origin of the observed material cannot be confirmed from the video.No sample was returned for evaluation.No confirmation can be made if the second mark/line is a foreign material or a scratch.A definitive determination of damage cannot be made without the evaluation of the physical product.The customer states the use of non-qualified viscoelastic.The use of an unqualified ovd (ophthalmic viscosurgical device)may cause damage to the lens and potential complications during the implantation process.A final root cause cannot be determined based on available information.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: 14885131
• Report Number: 9612169-2022-00309
• Device Sequence Number: 17696186
• Product Code: MJP
• UDI-Device Identifier: 00380652410724
• UDI-Public: 00380652410724
• 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): 09/22/2022

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: CNW0T5
• Device Lot Number: 21285353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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; HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 84 YR
• Patient Sex: Female