MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number CNA0T0

Device Problem Scratched Material (3020)

Patient Problems Inflammation (1932); Red Eye(s) (2038); Visual Impairment (2138); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Infections (4466); Eye Pain (4467); Unspecified Eye / Vision Problem (4471)

Event Date 12/06/2023

Event Type  Injury  

Event Description

A facility representative reported that following an intraocular lens (iol) implant procedure, the eye where the lens was placed has a watery shadow and a scratch appears as if it were a root, constant burning and pain and a lot of discomfort with lighting.Additional information has been requested, received and stated the patient returned to the clinic after initial implant and was seen by another doctor (not the same one who performed the surgery).Ocular edema and herpes were suspected.No diagnosis was confirmed by the doctor.The patient returned to the clinic again one week later, and the doctor kept the same medication and didn't order any exams.He said he suspected herpes and that the edema that had appeared was smaller.After a month, the patient needed to go to the hospital's emergency service and followed the same procedures as the clinic.No exams or medication were prescribed.The patient returned after 2 weeks and was told to see a specialist.Tests were ordered and the patient was prescribed to continue taking corticosteroids.The professionals informed him that the herpes had been cured, but no specific exams were requested.One month later, the patient went for a consultation with the specialist, and she informed him that there was ocular inflammation and changes in the condition of the eye, which was confirmed by the exams carried out and the loss of vision.The loss of vision was diagnosed through an examination carried out in the consultation and will be carried out other tests to complement it.Regarding the herpes, tests have been carried out and the results will be ready by next month.It was also mentioned the patient had redness, constant sharp pain, burning, shading, difficulty blinking due to pain, tearing of yellowish liquid, loss of vision.A new appointment was scheduled for next month.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• 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: 18887451
• MDR Text Key: 337459462
• Report Number: 9612169-2024-00211
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393751
• UDI-Public: 00380652393751
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25660225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male