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

Model Number	CNW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hyperemia (1904); Hypopyon (1913); Keratitis (1944); Fibrosis (3167)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure the patient experienced endophthalmitis which was confirmed on the second day after surgery with presence of key findings fibrin and hypopyon.No surgical treatment was performed but the patient was treated with steroid eye drops and antibacterial eye drops.The lens was remained in patient eye and the event outcome was resolving.Additional information has been received stating subjective symptoms of blurred vision from the second day after surgery with inflammation findings, hyperemia, keratic precipitates (kp) and fibrin with no iol defect.There are two medical device reports associated with this complaint.This report is 2 of 2.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in d.4.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: 20341389
• Report Number: 9612169-2024-00980
• Device Sequence Number: 7931269
• Product Code: MJP
• UDI-Device Identifier: 00380652409667
• UDI-Public: (01)00380652409667(17)261101(11)221103(10)25517753(21)25517753163
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: CNW0T3
• Device Lot Number: 25517753
• 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: 09/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/29/2024
• Date Device Manufactured: 11/03/2022
• 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: 0.4 PERCENTAGE TRYPAN BLUE SOLUTION.; BSS PLUS STERILE INTRAOCULAR IRRIGATING SOLUTION.; DECADRON INJECTION.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; OVD (OPEGAN AND SODIUM HYALURONATE).; XYLOCAINE INJECTION 1 PERCENTAGE.; XYLOCAINE OPHTHALMIC SOLUTION 4 PERCENTAGE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male