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

Model Number CC60WF

Device Problem Material Opacification (1426)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

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.Photos were available in the file.One image showed a dark colored handle of an unknown instrument.The other image is a magnified view of a computer monitor system.The monitor screen showed the lens inside the eye with only a portion of the lens captured in the viewing area.In this image, there appears to be a circular area near the optic edge.It cannot be determined from the photo if this observation is dried viscoelastic, an anomaly of the lens, or damage to the lens material.Without the sample to evaluate, a clarification is not possible for this image.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that following an intraocular lens (iol) implant procedure, the surgeon noticed opacification on the lens in the bottom left corner.Additional information has received and stated that there was no patient harm.As per the surgeon, the imperfection is not in the patients visual field and patient is not having any issues at present.

• 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: 18072292
• MDR Text Key: 327358976
• Report Number: 1119421-2023-01865
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652396882
• UDI-Public: 00380652396882
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 15604529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV, INJECTOR; LENS LOADING FORECEPS; MONARCH III CARTRIDGE D; PROVISC
• Patient Age: 61 YR
• Patient Sex: Male