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

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Dizziness (2194); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following intraocular lens implantation, patient was absolutely disoriented and can not work and surgeon targeted for near for intraocular lens (iol).Patient also complained of dizziness and lightheadedness at work and felt foreign body sensation surgeon aimed at -1.75 at patient request and on target.Surgeon tried trial frame to show patient change it made patient dizzy and disoriented, then surgeon places trial contact -2.00 and patient reported better vision and reported no dizzy or disorientation.Patient decided for iol exchange in right eye.Surgeon suggested that she will need readers after surgery and patient agreed to it.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information was provided in b.5., h.3., h.6.And h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product was not returned.The surgeon indicated the issue was unrelated to the intraocular lens (iol).The surgeon aimed -1.75 at patient request and results were on target.Patient did not like the results.The surgeon placed a trial contact -2.00 lens and the patient reported much better vision.Information was provided that the patient decided not to have a lens exchange.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The company is a monofocal lens which corrects for one distance (near or far) as targeted by the surgeon.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that there was no lens issue and issue was the patient changed her mind and did not like the original target.Additional information received and stated that the event was resolved.

• 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: 24494416
• Report Number: 1119421-2026-00435
• Device Sequence Number: 5092079
• Product Code: HQL
• UDI-Device Identifier: 00380652251471
• UDI-Public: (01)00380652251471(17)280916(11)240918(10)15921739
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: SY60WF
• Device Catalogue Number: SY60WF.195
• Device Lot Number: 15921739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 09/18/2024
• 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: ARGOS BIOMETER.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female