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

Model Number	CNA0T0
Medical Device Problem Codes	Failure to Advance (2524); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.A manufacturing batch record review and a non-conformance review of the reported batch number was conducted.No deviations were identified and all corresponding production release specifications defined in the medical device file were met.The reporter states the use of "hiluron -1.4%" as a viscoelastic, which is not qualified to be used with the associated product.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the customer states the use of a non-qualified viscoelastic.The use of an unqualified ophthalmic visco surgical device (ovd) may cause damage to the lens and potential complications during the implantation process.Other potential contributing factors to the reported event include: if the lens has become misaligned in the lens bay during the manufacturing process.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 or become "stuck" in the device allowing the plunger to override the lens.If the operating room temperature is too high (> 23 degrees celsius/73 degrees fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.If ovd has not been allowed to come to operating room temperature over a 20 minute timeframe prior to use.Colder temperatures can increase the ovd viscosity, creating greater resistance during intraocular lens (iol) delivery, causing potential unsuccessful delivery outcomes.Any of the above listed causes alone, or in combination, may create the reported event.Based on the results from the manufacturing batch record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during intraocular lens (iol) implantation surgery while the iol being inserted into the patient eye the plunger override and resulted, the scratch on lens with patient contact.The surgery was completed on the same day.Additional information received stating the event occurred while injecting in the eye.The surgery was completed and the same lens implanted.

• 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 fwy; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 25552159
• Report Number: 9612169-2026-01367
• Device Sequence Number: 16137587
• Product Code: HQL
• UDI-Device Identifier: 00380652393799
• UDI-Public: (01)00380652393799(17)281201(11)251203(10)26169034
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 26169034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 12/03/2025
• 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: HILURON - 1.4%
• Patient Sex: Unknown