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

Model Number	CCWTT6
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, lens was explanted due to toric markings being in the wrong place.Additional information has been requested and received stated that the marks for the toric are in the wrong place on the lens.There is a manufacturing error.
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 the reported complaint was not observed.Toric axis marks were within specifications.Iol (intra ocular lens) returned wrapped in a wipe in a clear zip lock bag.Solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is cracked/fractured split in two and scratched/marked-rejectable.The iol met specifications when dimensionally measured for edge thickness and plan view.The axis marks are within specification.No root cause identified as the reported complaint "toric markings in wrong place" was not observed, the returned iol met specification when dimensionally measured for edge thickness and plan view, the axis marks are within specification.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL 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: 15028189
• Report Number: 9612169-2022-00340
• Device Sequence Number: 20422465
• Product Code: MJP
• UDI-Device Identifier: 00380652458849
• UDI-Public: 00380652458849
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 12/04/2025
• Device Model Number: CCWTT6
• Device Catalogue Number: CCWTT6.135
• Device Lot Number: 25322681
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown