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

Model Number	CCWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Red Eye(s) (2038); Capsular Bag Tear (2639)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned inside a non-company self sealing pouch in a biohazard bag.Viscoelastic and blood were dried on the lens.One haptic was bent with distal tip adhered in dried solution to the optic.The other haptic was extended.The optic was cut into pieces.The lens was cleaned with klrp for further evaluation.One haptic distal area was nicked on the posterior and split on the posterior edge.The anterior distal area has scratches.One optic portion was cracked from the edge travelling inward in the outline of an instrument used to grasp the lens.The optic posterior was cracked near the cut line of damage.The other optic portion was cracked near the cut line of damage.Each lens is 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.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were used.The root cause cannot be determined for the reported complaint of "lens explanted due to incorrect lens power, torn capsule bag".The explanted lens was returned cut into pieces with additional damage.Each lens is 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 provide that the company (2.25 cyl.) 17.0 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a non-company monofocal lens.The diopter information of the monofocal replacement lens was not provided.Due to the exchange of a multifocal toric lens for a monofocal lens, this suggests that a monofocal lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient was unhappy with vision due to incorrect lens power.The iol was exchanged for non-company lens.New lens was not implanted due to a torn capsule bag.Patient will return to operation room (or) for a lens to be sutured in.Vitrectomy needed, suture of wound and incision enlargement needed.Capsule bag not intact.Additional information has been requested.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 20755660
• Report Number: 1119421-2024-02284
• Device Sequence Number: 20938141
• Product Code: MJP
• UDI-Device Identifier: 00380652457859
• UDI-Public: (01)00380652457859(17)261212(11)221214(10)15554335
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: CCWTT4
• Device Catalogue Number: CCWTT4.170
• Device Lot Number: 15554335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING; ORA SYSTEM WITH VERIFEYE MESSAGING, CART
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female