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

Model Number	CCW0T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fibrosis (3167); Unspecified Eye / Vision Problem (4471)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that patient had 2+ cell and fibrin in anterior chamber with good vision, no pain, no redness and was treated with steroids.Additional information has been requested, received and stated that post-op day 1 the patient had more inflammation than usual without signs of infection, no pain, has good vision, no vitreous cells, no injection.Aqueous cell 2+ and aqueous fibrin present.The patient had blepharitis.Topical medication adjustment was done.No cultures taken.This report is associated with multiple complaints.This file is 3 of 3.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports will be submitted.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received, reporting that the inflammation was likely related to lidocaine/epi mixture compounded at surgicenter by new staff that used preserved lidocaine, there is nothing to do with the intraocular lens (iol).

• Brand Name: CLAREON TORIC UV ABSORBING 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: 18823969
• Report Number: 9612169-2024-00170
• Device Sequence Number: 2970310
• Product Code: MJP
• UDI-Device Identifier: 00380652432795
• UDI-Public: 00380652432795
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CCW0T4
• Device Catalogue Number: CCW0T4.155
• Device Lot Number: 25528224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 04/14/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: ALPHAGAN 0.1%; MOXIFLOXACIN; PREDNISOLONE ACETATE; SURGICAL PRODUCT, UNSPECIFIED; TIMOLOL 0.5%
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female