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

Model Number	PXCWT3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Conjunctivitis (1784); Corneal Edema (1791); Inflammation (1932); Intraocular Pressure Increased (1937); Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient had tass (toxic anterior segment syndrome) one day post op, with inflammation confined to the anterior chamber.Unspecified topical steroids were started and follow up has been scheduled.Additional information has been requested, received and stated tass onset was seen a post-op day 1.Cultures were not done.Conjunctival inflammation, aqueous cells and aqueous fibrin were present.Post op day 6, the patient had eye pain, trace corneal edema and scleral redness.Medication adjustments were made, noted potential for surgical intervention of lens rotation due to blurry vision from 031 degree to 180 degree.Inflammation & fibrin improving.(b)(6) 2025 visit visual acuity 20/40, intraocular pressure was noted as increased and treated topically with unspecified medication.Additionally, surgeon stated there was nothing out of the ordinary or significant to be noted as far as the surgical process was concerned.All sterilization records were sufficient and within parameters.No breaks in process or policy were noted.So far this remains an isolated instance.
Event or Problem Description
Additional information was received that the patient had undergone intraocular lens repositioning surgery on post-operative day twenty nine.The patient was evaluated one day post intraocular lens repositioning surgery and was noted with mild inflammation which was expected to improve and vision was blurry.The patient will be further monitored due to additional surgery for significant findings.
Additional Manufacturer Narrative
Additional information provided in b.5., b.6., d.10., e.4., h.3., h.6.And h.11.The product was not returned for analysis.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The root cause for the reported complaint could not be determined.No sample was returned for analysis.The sterilisation reports were reviewed and there were no issues with the sterilisation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information indicated that the most recent chart note was from a nine-day postoperative visit following intraocular lens (iol) repositioning.The blurriness had improved, although the vision remained somewhat blurry.However, the general postoperative appearance was good, with no signs of toxic anterior segment syndrome (tass).The patient was advised to return for serial refractions at future visits.
Additional Manufacturer Narrative
Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON PANOPTIX PRO TORIC TRIFOCAL 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: 22283244
• Report Number: 9612169-2025-01246
• Device Sequence Number: 20914750
• Product Code: MJP
• UDI-Device Identifier: 00380658433987
• UDI-Public: (01)00380658433987(17)290818(11)240820(10)25895273
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PXCWT3
• Device Catalogue Number: PXCWT3.210
• Device Lot Number: 25895273
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/15/2025; 08/12/2025
• Date Device Manufactured: 08/20/2024
• 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: 0.75 SENSORCAINE.; 1% CYCLOGYL.; 1% MYDRIACYL.; 10% NEOSYNEPHRINE.; ALCON MICROSURGICAL INSTRUMENTS CANNULA OPHTHALMIC.; ALCON MICROSURGICAL IRRIGATING CYSTITOME.; BETADINE 5%.; BROMFENAC DROPS 0.075%.; BSS STERILE IRRIGATING SOLUTION,.; CENTURION SURGICAL PROCEDURE PAK.; CLEARCUT INTREPID KNIVES.; CLEARCUT KNIVES.; CUSTOM-PAK SURGICAL PROCEDURE PACK.; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; DUREZOL DROPS 0.05%.; INTRACAMERAL LIDOCAINE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MOXIFLOXACIN DROPS 0.5%.; POLYMER & SILICONE IRRIGATION & ASPIRATION TIPS.; POVIDONE IODINE 10%.; PREDNISOLONE DRIP 1%.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; TETRACAINE 0.5%.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.; XYLOCAINE 2% JELLY.; ZYMAXID, ACULAR, BETADINE SWAB TO THE EYE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female