MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	CC60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/11/2024
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 non-healthcare professional reported with a description of broken capsule upon insertion of iol.There are two medical device reports associated with this complaint.This report is 1 of 2.Additional information has been received stating no patient harm.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned inside a plastic specimen jar.Solution was dried on the lens.The optic was cut into pieces, typical of an insertion and removal.One optic portion was broken on the posterior optic edge.This optic portion was also cracked and split from one area of the edge, across the optic central area, travelling toward the opposite side of the optic.Product history records were reviewed, and the documentation indicated the product met release criteria.Information indicated that a non-qualified company cartridge was used.The suspect device was beyond the range qualified for use in the used cartridge.This lens model was qualified for the diopter range 6.0 through 25.0.This suspect device 25.5 diopter lens would be qualified for use in a different model company cartridge only.The viscoelastic and handpiece are qualified for this lens when used with a qualified cartridge.The root cause cannot be determined for the reported complaint of "broken capsule upon insertion".The lens was returned cut into pieces, typical of an insertion and removal.The optic was cracked, split almost into additional pieces, and the optic edge was broken.A failure to follow the instruction for use (ifu) was also observed with the use of a non-qualified cartridge.The ifu instructs: company foldable intraocular lens (iols) is qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 19328892
• Report Number: 1119421-2024-00943
• Device Sequence Number: 3101817
• Product Code: HQL
• UDI-Device Identifier: 00380652396936
• UDI-Public: 00380652396936
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: CC60WF
• Device Lot Number: 15576580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MCPHERSON / LENS LOADING FORCEPS; MONARCH III CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown