MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET5
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced a significant myopic refractive outcome, specifically -8.00 spherical (sph) and -1.25 cylindrical (cyl), which was not the intended result.Importantly, the surgery itself was uncomplicated, and the post-operative examination did not reveal any notable issues.The planned iol power for the patient was 16.0, with a target refraction of plano (zero spherical correction) for distance vision.To investigate the unexpected refractive outcome, two separate iol calculations were performed using different devices, both of which confirmed similar axial lengths of approximately 24mm.Moreover, the keratometry readings obtained were consistent with the corneal topography.Additional information has been received and stated that the patient was high myopic surprise from a lens.Preoperatively, surgeon have performed two separate iol calcs from two separate machines, which confirmed consistent axial lengths in the 24mm range, and consistent keratometry that matched a corneal topography.Surgeon chosen a toric iol for distance.The surgery was uncomplicated, and the postoperative exam was also unremarkable with the iol in the bag.The lens sticker is confirmed to be a target for distance (16.00d ).The postop refractive result = -8.00 sph -1.25 cyl = 20/25.Surgeon confirmed this with a retinoscopy.Surgeon only conclusion is that the lens was manufactured poorly or there is an erroneous lens placed inside the packaging.The amount of refractive error would require an axial length or other calcs to be off by whole millimeters.Nor would a flipped toric cause this.Since there is no other pathology, surgeon cannot think of an intraocular cause for this as well.Lens was replaced with another company lens.
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).
Additional Manufacturer Narrative
The product was returned for analysis.The lens was returned in a specimen container.Solution is dried on the lens.The optic is cut in half, the optic also has additional cuts and scratches.One haptic is broken/torn and is returned.The lens was sterilized and measured by r&d engineer (odonosh3) in r&d pilot line and was confirmed not matching the model and dioptre than stated on the label.Photo shows implanted iol.3 dots are visible on the iol optic at the gusset location.Toric marks confirmed.The root cause is deemed to be manufacturing related.Incorrectly labelled product was released.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17816155
• Report Number: 9612169-2023-00673
• Device Sequence Number: 2342922
• Product Code: MJP
• UDI-Device Identifier: 00380652455923
• UDI-Public: 00380652455923
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/20/2023

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: 11/25/2025
• Device Model Number: CCWET5
• Device Catalogue Number: CCWET5.160
• Device Lot Number: 25318638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male