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

Model Number CC60WF

Device Problem Defective Device (2588)

Patient Problems Eye Injury (1845); Headache (1880); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A non-healthcare professional reported that following a cataract extraction with intraocular lens (iol) implant procedure, the implanted lens was defective and caused trauma in the eye.The eye was swollen and unable to open for 4 days.The eye kept watering nonstop and also pain in eye area and headache for 6 days and lost time at work and eye stilled did not open up fully until week 3.The eye is now sensitive to bright light and requires sunglasses at work and around the house, blur vision.Additional information was requested and received from the initial reporter, who stated that this event has affected me, my daily life, and my work in several ways.The left eye still has not healed 100 percent, and i still do not have a prescription for corrected eye glasses because it has not healed.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The lens remains implanted.The reporter was the patient.The implanting facility provided the following information.When the initial iol was inserted in the patient's eye it appeared the back haptic was damaged, the iol was removed and this iol was placed without incident.Information was provided that the first day post op for the left eye the patient had not been using their eye drops as instructed.The patient's vision at the 1-day post-op, (b)(6), was 20/300 with inflammation present.On (b)(6), the patient's vision was 20/150 with improvement of the inflammation.Was there patient harm-no.The patient's vision before surgery was 20/300, last post-op visit it was 20/80 pinhole.The surgeon's prognosis is that the patient will continue to improve.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(6).

Event Description

Additional information was requested and received from the initial reporter who stated that left eye was still having issues of cloudiness.There was a haze on the left eye toward the left side of the eye.

• Brand Name: CLAREON ASPHERIC UV ABSORBING 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: 16494145
• MDR Text Key: 310777149
• Report Number: 1119421-2023-00400
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652396714
• UDI-Public: 00380652396714
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 15458870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV INJECTOR.; MONARCH III CARTRIDGE D.; PROVISC.
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female