MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that during the intraocular lens (iol) implant procedure the lens was cracked and trailing haptic was bent.The procedure was completed with replacement lens during the initial procedure.There was patient contact with the lens.Additional information was requested and received that no patient harm reported.The symptoms has been resolved.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the lens.Iol returned between two pieces of clear sellotape tape like material.Unable to remove iol from between tape.Residue can be seen on the iol.Both haptics are broken/torn and are returned.The iol is torn/split-cut into seven pieces and is scratched/marked-rejectable.The complainant indicates the use of non company viscoelastic as an ovd, which is not qualified to be used the associated iol model.The root cause may be related to failure to follow ifu.The surgeon states the use of non-qualified combination.The use of non-qualified combinations may result in delivery issues and/or damage.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17583720
• Report Number: 9612169-2023-00603
• Device Sequence Number: 20034117
• Product Code: POE
• UDI-Device Identifier: 00380652405836
• UDI-Public: 00380652405836
• 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,Followup
• Report Date (Section B): 12/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.230
• Device Lot Number: 25307243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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: AMVISC.; CARTRIDGE D.; MONARCH III INJECTOR.
• Patient Age: 61 YR
• Patient Sex: Male