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

Model Number SY60WF

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Irritability (2421)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device 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 manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that an unknown white material stuck on the intraocular lens (iol) was noticed during implantation.The surgeon scratched the material off the iol and removed it from the eye.It was also reported that the material was not from the sterile field, and the lens came like that.The lens remains implanted in the patient's eye.Additional information received stated that patient's right eye was affected and the patient had chemical irritation.The symptoms were not resolved.

• 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: 17070023
• MDR Text Key: 316605095
• Report Number: 1119421-2023-01035
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652251518
• UDI-Public: 00380652251518
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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.215
• Device Lot Number: 15363876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 66 YR
• Patient Sex: Female