MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Type of Reportable Event	Serious Injury
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
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced halos.The iol was exchanged for another lens model following the initial implant procedure due to severity.Additional information was requested and received stating that the patient did not feel driving safe and prognosis was good.
Additional Manufacturer Narrative
The lens was returned submerged in clear liquid inside a small plastic specimen jar.The lens was removed from the liquid and allowed to air dry prior to evaluation.Solution residue was observed on the lens.The left side of the optic has rows of cracked damage that travelled from the optic edge toward the optic center.These rows of damage were directly opposite each other on the anterior and posterior surfaces of the optic in the shape of an instrument used to grasp the lens.The right side of the optic has the same type of rows of cracked damage in the shape of an instrument used to grasp the lens.The right side of the optic was also split on the posterior.The optic edge on the left side was split toward the central rings.The optic was also split (cut) from the edge travelling horizontally through the central optic rings toward the optic center.At the optic center the split damage enlarged to involve cracked damage.This extreme damage travelled downward through the optic center and through the optic rings almost to the other side of the optic edge.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece and viscoelastic.The root cause cannot be determined for the reported complaint.The lens was returned with extreme damage.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal 19.0 diopter lens.This information that a multifocal 18.5 diopter lens was replaced with a monofocal 19.0 diopter lens, and the questionnaire response indicating that the patient's issues have resolved, would suggest that the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 19173211
• Report Number: 1119421-2024-00788
• Device Sequence Number: 20797326
• Product Code: MFK
• UDI-Device Identifier: 00380652413619
• UDI-Public: 00380652413619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.185
• Device Lot Number: 15715360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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; MONARCH II LOADING FORCEPS; MONARCH III CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female