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

Model Number	CNW0T8
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient reason vision out of focus.Clinical reason being mentioned as iol (intraocular lens) rotation 90 degree after surgery x 2.The iol was explanted and exchanged for an unknown monofocal lens in the secondary implant procedure.Additional information has been requested.
Event or Problem Description
Additional information has received it states that the patient experienced significant inflammation and iop(intraocular pressure) elevation after the lens exchange.Doctor informed patient had iol rotation twice.He underwent 3 surgeries and 15 post-operative visits with significant elevation of intraocular pressure (iop) at times and need for additional medications.The issues eventually resolved without any apparent permanent damage.The prognosis was excellent.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Additional information has been provided in b.5., b.6., h.6.And h.11 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: 20748314
• Report Number: 9612169-2024-01214
• Device Sequence Number: 18235565
• Product Code: MJP
• UDI-Device Identifier: 00380652411950
• UDI-Public: (01)00380652411950(17)271011(11)231013(10)25733789
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNW0T8
• Device Lot Number: 25733789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/24/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/23/2024
• Date Device Manufactured: 10/13/2023
• 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: REPLACED WITH MONOFOCAL LENS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown