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

Model Number CC60WF

Device Problem Failure to Advance (2524)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The used lens appeared to be replaced into the associated company cartridge for return shipment inside the lens carton.Viscoelastic was observed on the lens.The lens was placed posterior surface up and located halfway into the loading area.The leading haptic was extended.The trailing haptic was folded onto the anterior surface of the optic and adhered in dried viscoelastic.There was no damage observed to the associated cartridge.Both wings display evidence of handpiece use.Product history records were reviewed, and documentation indicated the product met release criteria.All listed associated products were qualified for use with the lens.The root cause cannot be determined for the reported complaint of "didn't eject properly, in and out".It is unknown what the customer meant by "didn't eject properly".The lens was returned replaced halfway into the loading area of the associated used cartridge.No damage was observed to the cartridge.Due to the method of return, no further determination can be made.+ the completed questionnaire indicated that in the surgeon's opinion, the product did not cause or contribute to the event.The root cause per the surgeon was unknown.Information was provided that the company lens was removed and replaced with the same model lens.The manufacturer internal reference number is: (b)(4).

Event Description

A non-health care professional reported that during an intraocular lens (iol) implant procedure,lens did not eject properly.Lens was explanted at initial procedure.Additional information was received.There was no patient harm.

• 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: 18765514
• MDR Text Key: 336085658
• Report Number: 1119421-2024-00332
• Device Sequence Number: 1
• Product Code: HQL
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 15706826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 68 YR
• Patient Sex: Female