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

Model Number SY60WF

Device Problems Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 provided photo and video were reviewed.The photo does not give enough clarity to make a determination.Review of the video does show a dark area with a circular appearance.Unable to determine if this is a bubble or material under or in the lens.The light reflective areas were visible in the video.This may be related to surface anomalies (dimple) or damage that is reflecting due to the angle or it may be something on the optic surface.Physical examination of the lens would be necessary to determine the nature and origin of the observed artifacts.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported during the intraocular lens implantation it was observed that a vacuole to the right of the bright purkinje reflex and there are multiple shiny defects or foreign bodies on the surface of the lens that were not removable.The lens was left in the eye.Additional information has been requested and received stating the patient was not hospitalized for the event and there was no medical intervention needed.The surgeon prognosis was possible need for an lens exchange.The symptoms are still ongoing.There is a possibility of harm if the vision does not recover.The surgeon thinks it is a manufacturing defect in the lens.Additional information has been received stating the patient is j1+ in the affected eye, which is her monovision reading eye.She has no subjective visual complaints but continues to see the shiny defects on the surface of the lens as well as one vacuole within the lens, even with the pupil undilated.They have agreed to not explant the lens.

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15867616
• MDR Text Key: 307701042
• Report Number: 1119421-2022-02492
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.225 CLAREON
• Device Lot Number: 15379081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BARRETT TRU K.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; UNSPECIFIED FORCEPS.
• Patient Age: 79
• Patient Sex: Female