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

Model Number	CC60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non healthcare professional reported that during an intraocular lens (iol) implant procedure, a crack was observed at junction of leading haptic and optic.The iol was explanted and exchanged with another iol.Additional information was received stating that it was noted that the lens failed to center.Further inspection revealed a crack in the iol haptic.The eye was refilled with ophthalmic viscosurgical devices (ovd) and the forceps and scissors were used to cut and remove the damaged iol.The bag was refilled with viscoelastic, and a new iol was inserted and rotated into position.The lens was well centered.The remaining viscoelastic was removed using the irrigation/aspiration handpiece.The anterior chamber was inflated with balanced salt solution (bss), and the temporal wound was hydrated and sealed.There was no patient harm, and the patient was not hospitalized as a result of this event.

• 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: 15538924
• Report Number: 1119421-2022-02121
• Device Sequence Number: 6990825
• Product Code: HQL
• UDI-Device Identifier: 00380652396745
• UDI-Public: 00380652396745
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 11/12/2024
• Device Model Number: CC60WF
• Device Lot Number: 15221069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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: BSS; CLAREON MONARCH IV INJECTOR; DUOVISC; MONARCH III CARTRIDGE D; UNSPECIFIED I/A HANDPIECE; UNSPECIFIED MST FORCEPS; UNSPECIFIED SCISSORS; VISCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female