MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Codes	Particulates (1451); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following the cataract surgery with intraocular lens implant procedure, the patient visited surgeon¿s office 30 hours later and when the tech examined the tech removed a ¿cover¿ from the inserted lens or the eye with a tweezer and expressed some surprise that it was still on the implant.The patient also reported that right eye was compromised (unspecified).Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
Additional information provided in h.11.Information was provided that the surgeon reminded the patient that they had been informed that they put a "medicated lens" (bandage lens) at the time of surgery.This medicated (bandage) lens is not related to implanted iol or the iol manufacturing facility.Bandage contact lenses are often applied after refractive surgery or cataract surgery to protect the eye during the initial healing phase.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in h.6.And h.11.On initial mdr the fda product problems code of a030205 was incorrect.It should have been a24 on the original mdr.Additional information provided in b.5.H.6.And h.11.Company lenses do not have covers that need to be removed after surgery.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, the patient took the second opinion concerning the health of the eye.The patient stated that vision was improved but no vivid colors and limited "clarity" and very little light sensitivity.The patient had halos or streaming lights from streetlights and headlights at night.The patient stated that she would receive prescription glasses in two weeks.The patient said she asked about the cover on the lens.The surgeon explained that a "medicated lens" was placed over the new lens during surgery.Most patients don¿t notice it because it naturally flushes out of the eye overnight and is found on the bandages the next day.The patient stated she was more alert and when my bandage was removed and again this medicated lens did not "flush off" during the night.When the removed lens was shown to patient it had the appearance of a soft contact lens and was moist looking.

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• 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 ; 8007579780
• MDR Report Key: 23035790
• Report Number: 1119421-2025-02456
• Device Sequence Number: 9329417
• Product Code: HQL
• UDI-Device Identifier: 00380652251358
• UDI-Public: (01)00380652251358(17)270628(11)230630(10)15671055
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.135
• Device Lot Number: 15671055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/15/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/06/2025; 11/09/2025
• Date Device Manufactured: 06/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female