MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported during intraocular lens (iol) implant procedure, upon insertion of iol, a scratched was noted on iol.The lens was explanted and replaced with another lens during initial procedure.The procedure was completed on same day.Additional information has been requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating no patient harm.
Additional Manufacturer Narrative
The lens was returned loose in a ziploc bag with the disassembled lens case inside the lens carton.Solution and blood were dried on the lens.The lens was cut into pieces, typical of an insertion and removal.One haptic was broken in the gusset area.The broken haptic was not returned.One optic portion has a linear scratch located on the posterior surface.The other optic portion has cracked damaged at the optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The reported scratch was observed.The optic was cut into pieces, typical of damage created to remove a lens from the eye.All lenses are 100 percentage (%) inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution, blood, and the condition of the returned sample, the damage is most likely related to customer handling.Information was provided that there was a lot of staff turnover.Four intraocular lens iol lens loading in-services were conducted at the reporting facility between june 2023 to october 2023.Customer affairs manager (cam) has continued to spend a lot of time in the operation room (or) with the surgeon and staff.They have stated many times that the loads have been very good over the last 4 to 6 months.Cam followed up and they reemphasized again that the loads have been good now that they have staff consistency.They never felt like it was a quality issue but rather a loading/staff issue.The instruction for use (ifu) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ophthalmic viscosurgical device (ovd)-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 18825825
• Report Number: 1119421-2024-00386
• Device Sequence Number: 7879345
• Product Code: POE
• UDI-Device Identifier: 00380652405799
• UDI-Public: 00380652405799
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.210
• Device Lot Number: 15597976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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 MONARCH IV INJECTOR; DUOVISC; MONARCH III CARTRIDGE D; UNSPECIFIED REPLACEMENT LENS
• Patient Age: 68 YR
• Patient Sex: Male