MAUDE Adverse Event Report: Alcon Research, LLC - Huntington CLAREON PANOPTIX PRO Toric Trifocal Hydrophobic IOL; Lens, Intraocular, Toric Optics

Model Number	PXYWT4
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient had difficulty seeing far.The patient could not see words or scores on tv, could not drive and read street signs, car headlights and any signage had very bright lights or halos.It was determined that the lens had folded over.The patient had additional surgery to unfold the lens.After the correction he/she could see near but continued to not see far.He/she was told that this issue happens sometimes and would need to get glasses to see far.Additional information has been requested, received and stated the patient had poor night vision.There are two medical device reports associated with this patient.This report is associated with the left eye.
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).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 Hydrophobic IOL
• Common Device Name: Lens, Intraocular, Toric Optics
• Manufacturer (Section D): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50855328
• Report Number: 1119421-2026-01925
• Device Sequence Number: 10053671
• Product Code: MJP
• UDI-Device Identifier: 00380658437244
• UDI-Public: (01)00380658437244(17)301012(11)251014(10)16129950
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PXYWT4
• Device Catalogue Number: PXYWT4.185
• Device Lot Number: 16129950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 10/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown