MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number SY60WF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Uveitis (2122); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

A sample device 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).

Event Description

A physician reported that following implantation of an intraocular lens (iol) the patient suspected to have allergic symptom appeared and patient was allergic to acrylic lenses.Additional information was requested and received stating fibrin continues to appear and is controlled with steroid eye drops, no edema.Patient hard to see, burred vision.In order to eliminate the possibility of the cause, in considering a possibility of allergies, first of all, he is thinking of performing a patch test at a dermatologist, which is less invasion for the patient.There are two medical device reports associated with this patient.This report is associated with the right eye.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was requested and received stating patient experienced allergic symptoms such as eye inflammation, fever, and nausea.Additional information was requested and received patient had been on steroid eye drops for one month postoperatively at his previous physician, during this period the patient was well with no onset of symptoms.After the steroids were cut off a month later, fever, nausea, and cells began to develop, fibrin deposition.The patient is currently in the hospital for a patch test and other tests.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received stating patient had been flare values are not as high as they used to be and are decreased, but they are still continually showing up (60 to about 20).Patient complains of blurred vision and some vitreous opacity due to inflammation.The patient was discharged from the hospital after a patch test of all intraocular lenses, including sy60wf and other companies' lenses, was conducted to confirm allergy.Physician commented that he did not know the cause.There is no infection.Additionally it was reported that patient was under observation and the anti-bacterial agent has been changed.The flare value was also decreased slightly.However, the specific values could not be confirmed with the doctor.The patient stated that he feels a little better.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received stating that the patient was coming to the clinic every 3 weeks to 1 month for follow-up.The flare value has been decreasing a little.The patient was no longer concerned about it and symptoms have settled down.Additionally it was mentioned that, it seems that the lens was not the cause of the symptoms.

• Brand Name: CLAREON IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15886393
• MDR Text Key: 304526267
• Report Number: 9612169-2022-00659
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male