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

Model Number CC60WF

Device Problem Malposition of Device (2616)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140)

Event Date 10/27/2022

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A materials manager reported that after implantation of intraocular lens (iol), the patient experienced blurred and distorted vision.The iol was explanted and replaced with monofocal iol within five months from the initial procedure.The clinical reason for explant was reported as decentered iol.Additional information was requested, but no further information is available.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified cartridge and viscoelastic.Per the information provided a monarch ii handpiece was used with the monarch iii d cartridge.The monarch ii handpiece will not physically accommodate the monarch iii d cartridge.This may have been reported in error.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the cc60wf, 22.5 diopter lens was replaced with a cc60wf, 21.0 diopter lens.Additional information was provided that the patient had prior myopic lasik surgery in 2008.The patient had pre-existing rm, ild bdr, was oag suspect and pvd.The exchange for a 1.5 lower diopter difference of the same lens model may suggest that the replacement lens was an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received stated that the iol did not cause or contribute to the event.In the surgeon's opinion blurred and distorted vision was caused by decentration of posterior capsular intraocular lens (pciol) anteriorly.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: 16282910
• MDR Text Key: 308618242
• Report Number: 1119421-2023-00224
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652396875
• UDI-Public: 00380652396875
• 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,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 15338529
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC UV ABSORBING IOL; MONARCH II IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; ORA SYSTEM WITH VERIFEYE MESSAGING, CART; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male