MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX PRO TRIFOCAL TORIC IOL W/AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	PXYAT5
Medical Device Problem Codes	Optical Decentration (1360); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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 physician reported that after an intraocular lens (iol) implant procedure, the lens was explanted for an unspecified issue.Additional information was received the lens was explanted for blurry vision and clinical reason for explant was disorder of intraocular lens (iol).
Additional Manufacturer Narrative
Correction information was provided in b.3., and b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received in the surgeon's opinion the product cause or contribute to the event was possibly difficulty with iol centration but narrow echelette diameters may make it less forgiving but if not then in the surgeon¿s opinion the product caused the event was asymmetry of zonular insertion to capsular bag.
Additional Manufacturer Narrative
Correction information was provided in h.6.On initial medical device report (mdr) the fda device codes of a26 was submitted.It should have been a0602.Additional information was provided in h.3.And h.11.It is stated in the file that in the surgeon¿s opinion it was asymmetry of zonular insertion to capsular bag that caused the event.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL TORIC IOL W/AUTONOME DELIVERY SYSTEM
• 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: 23641147
• Report Number: 9612169-2025-02349
• Device Sequence Number: 9785709
• Product Code: MJP
• UDI-Device Identifier: 00380658495183
• UDI-Public: (01)00380658495183(17)300303(11)250305(10)25993283
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: PXYAT5
• Device Catalogue Number: PXYAT5.170
• Device Lot Number: 25993283
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/27/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/19/2025; 02/20/2026
• Date Device Manufactured: 03/05/2025
• 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: REPLACEMENT ATIOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown