MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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 the manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, the lenses were damaged coming out of the injector.One of the lenses was injected in the eye and had to be removed.Additional information has been requested and received that additional incision required and symptoms were resolved and patient wound was healing and progressing.
Additional Manufacturer Narrative
The product was returned for analysis and damage to the lens was observed.Iol was returned outside of the device.The device was received loose in the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the nozzle.The plunger is bent at a right angle; this could be due to the device being returned loose in the carton.The lens was returned outside of the device wrapped in paper.Solution is dried on the iol.The iol is split in two.One haptic is broken torn and is returned, the other haptic is broken torn and not returned.Received photo shows 2 autonome device along with their respective cartons.The sn is present on the cartons.The device beside the carton for this complaint has a plunger which is extended outside of the device.The iol is outside of the device, the optic appears to have a line/crack on it and no haptics are attached to the optic.One haptic is broken torn and resting beside the optic.An additional photo shows an implanted iol, a tweezers and surgical blade are present, there appears to be damage to the iol.The product investigation could not identify the root cause for the reported complaint "damaged lens," as the lens was returned outside of the device.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.The lens was returned split in two, which is consistent with lens having been explanted.Lens damage may occur: ¿ due to the use of a non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to underfill, overfill, misfolding, delivery issues and /or damage.¿ if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly and cause delivery issues and /or damage.¿ if the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement and cause delivery issues and / or product damage.Any of the above listed causes alone, or in combination, may create the reported event.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol/device contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 24333231
• Report Number: 9612169-2026-00331
• Device Sequence Number: 17346155
• Product Code: HQL
• UDI-Device Identifier: 00380652393799
• UDI-Public: (01)00380652393799(17)271217(11)241218(10)25963502
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25963502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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 IOL; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female