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 08/23/2022

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 one other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A material manager reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced distorted and blurry vision.The clinical reason was decentered posterior chamber intra ocular lens.The iol was explanted and replaced with monofocal lens.Additional information has been requested.

Event Description

Additional information has been requested and received stated that lens was decentered with inferior tilt, possibly a haptic issue.There was no patient harm.The surgeon prognosis was good and the patient was not hospitalized.The issue has been resolved after the iol exchange.No further information available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information provided in h.3., h.6.And h.10.The account indicated the use of a qualified associated cartridge and viscoelastic.The handpiece indicated is not qualified for the lens/cartridge combination used.The company lens model is only qualified for the company handpiece.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 22.5 diopter lens model was replaced with a 21.5 diopter lens model due to a decentered lens.Additional information was provided that, in the surgeon's opinion, the doctor was unsure what caused the event.It was indicated the doctor believed it could be related to a haptic issue.The account used an unqualified lens/cartridge/handpiece combination.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.It was also reported the patient had prior hyperopic lasik surgery.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• 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: 16146302
• MDR Text Key: 307171644
• Report Number: 1119421-2023-00083
• 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,Followup
• Report Date: 03/17/2023

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: 15337200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/10/2023; 02/17/2023
• Supplement Dates FDA Received: 02/08/2023; 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON IOL; MONARCH CARTRIDGE D; MONARCH INJECTOR; PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female