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 Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, the patient had an hyperopic outcome of +2.25.Additional information has been received and stated that, the patient was not dilated at post operation.The next day they did an iol explant and during surgery, once patient was dilated, it was noted the iol leading haptic was "fractured" and iol was dislodged and decentered and which was seen on the monitor.The iol was shifted to the right and the edge of the lens was in visual axis.During the explant, the surgeon went to grab the leading haptic with the forceps and it came off.Surgeon explained to the reporter usually he would have to cut the haptic.The lens was removed without complication and a new lens was implanted after measuring with the system.The patient had requested to have better reading vision in this eye so a different power lens was used.Patient is very happy with the new lens.Also reported that, during the initial surgery, the haptic fracture was not noted.The reporter is the scrub tech who was in both surgeries.She said on implantation they hold the trailing haptic so there was no way they caused the issue to the leading haptic.
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol.Iol returned in an unknown liquid.Iol is cut in half through the center of the optic.One haptic is broken/torn.The product investigation could not identify the root cause for the reported complaint "leading haptic fracture".Only the iol was returned for evaluation.Cartridge was not returned.Lens and haptic position for the advancement cannot be confirmed.Due to this, we are unable to complete a thorough investigation to determine a root cause.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: 16545184
• Report Number: 9612169-2023-00218
• Device Sequence Number: 12359630
• Product Code: POE
• UDI-Device Identifier: 00380652405843
• UDI-Public: 00380652405843
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.235
• Device Lot Number: 25307342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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: CLAREON INJECTOR; CLAREON IOL; MONARCH CARTRIDGE C; ORA; PROVISC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female