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

Model Number CC60WF

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

Patient Problems Itching Sensation (1943); Uveitis (2122); Ptosis (2620); Eye Infections (4466)

Event Date 03/22/2023

Event Type  Injury  

Event Description

A non-healthcare professional reported following an intraocular lens (iol) implant procedure, the patient experienced itchy eye, used a drop of steroid, vision became blurry, eyelid swelled up.Additional information was requested.

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).

Manufacturer Narrative

Additional information provided in b.5.,b.7.And h.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received indicating that the patient had been diagnosed with ptosis in the right upper lid, which was notably swollen.Additionally, patient had been diagnosed with uveitis since the cataract surgery.Patient had planned to see their primary care physician due to an eye infection in the right eye, as patient felt it was infected due to the swollen lid.At that time, patient had switched to a different corticosteroid from the one they had previously been using.

Manufacturer Narrative

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

Event Description

Additional information was received as the consumer called back and reported that the patient was still experiencing problems and had been seeing multiple doctors.Patient had been diagnosed with dry eyes but had stopped using drops since they had experienced so many issues.Patient eyelids still were not healed.

• 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: 17118830
• MDR Text Key: 317068796
• Report Number: 1119421-2023-01102
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652396899
• UDI-Public: 00380652396899
• 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: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 15540308
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DEXAMETHASONE; PREDNISOLONE DROPS; RESTASIS
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female