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

Model Number	CC60WF
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned inside a sealed non-company pouch.Solution and blood were dried on the lens.One haptic was broken in the gusset area.The optic was cut into two portions, typical of damage created to remove a lens from the eye.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a non-qualified cartridge.The diopter of this lens model is beyond the qualified range for use in the company cartridge.The 27.0 diopter of the company lens is qualified for use in the company only.A company handpiece and a qualified viscoelastic were indicated.The reported broken haptic damage was observed.The root cause for the reported complaint is most likely related to a failure to follow the ifu.A non-qualified cartridge was used.The instruction for use (ifu) instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The reported complaint was for "broken haptic"; however an iol exchange for a difference equal to or greater than two diopters, would also indicate the event is related to a calculation error.Based on the information provided, the event does not appear to be related to the product.The company 27.0 diopter lens was removed and replaced with a company 29.5 diopter lens.This information suggests that the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that, following the intraocular lens (iol) implant procedure, the iol was exchanged to another lens due to broken haptic.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: 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: 17641305
• Report Number: 1119421-2023-01519
• Device Sequence Number: 20771526
• Product Code: HQL
• UDI-Device Identifier: 00380652396967
• UDI-Public: 00380652396967
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2026
• Device Model Number: CC60WF
• Device Lot Number: 15346035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Date Device Manufactured: 02/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON AUTONOME DELIVERY SYSTEM; DISCOVISC; DISCOVISC; MONARCH INJECTOR; MONARCHCARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female