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

Model Number	CNA0T0
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
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 health care professional reported that during an intraocular lens (iol) implant procedure, at the end of the iol implantation noticed that the lens was in superman position (anterior haptic was overextended and not folded) and the lower haptic was positioned diagonally in the shooter, next to the blue stamp at the bottom.Since it was a more complicated and smaller eye, the implantation of the superman lens requires a special rotation/placement and since the same diopter lens was no longer available two other lenses with a +0.50 diopters difference were opened, and it was noticed that all lenses were in this extreme superman position and also that the lower haptic was not centered (posterior haptic) was lying next to the blue shooter.As there were no more suitable lenses available, the first lens was chosen and implanted.As mentioned, it had to be rotated, which was possible without complications but was tedious and the surgery was completed without complications.However, the potential risk of complications due to the intraocular rotation/turning required (capsular rupture, lens dislocation) was higher than with a correctly placed lens in the shooter, and the surgery time was delayed.Additional information was requested and received it stated that five iols was affected.The 21.50 diopter lens was implanted by the surgeon by rotating the lens in the eye.Surgery was on the right side and other lenses did not come into contact with the eye.
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3., h.6.And h.11.The product was returned for analysis, and the reported complaint was observed.The device was returned loose in a plastic bag.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger and lens have been advanced at the mid nozzle area, and the plunger is slightly advanced over the iol (intraocular lens) causing the trailing haptic and optic damage.Straight leading haptic observed.Received photo shows activated device.The iol is in the mid nozzle.The plunger appears to be at the rear of the haptic/optic, the exact position of the plunger cannot be confirmed from the returned photo.The leading haptic appears to be extended straight.The reporter states the use of non company viscoelastic, which is not qualified to be used with the associated product.Plunger override was observed, which caused damage to the lens and the trailing haptic.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow ifu (instructions for use), as the customer states the use of non-qualified viscoelastic.The use of an unqualified ovd (ophthalmic viscosurgical device) may cause damage to the lens and potential complications during the implantation process.Straight leading haptic was also observed.The presentation of straight-leading haptics is addressed in the product instructions for use (ifu), where it is provided that delivery may proceed with caution and should be managed based on the outlined instructions.While straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated factors may also include: use of a non-qualified viscoelastic or bss in the delivery system.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Excessive delay between device preparation and subsequent delivery resulting in the potential for haptic unfolding.Use of the delivery system at operating room temperatures outside of the recommended range of 18 °c (64 °f) to 23 °c (73 °f).Ovd should be allowed to come to operating room temperature over a 20 minute timeframe prior to use.Any of the above factors alone, or in combination, may led to an event such as reported.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: 24279154
• Report Number: 9612169-2026-00267
• Device Sequence Number: 8318453
• Product Code: HQL
• UDI-Device Identifier: 00380652393744
• UDI-Public: (01)00380652393744(17)280911(11)250913(10)26109627
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 04/10/2026

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: 26109627
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2025
• 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: CLAREON IOL AUTONOME DEL SYSTEM.; CLAREON IOL AUTONOME SYSTEM.; CLAREON IOL WITH DEL SYSTEM.; CLAREON IOL WITH DELIVERY SYSTEM.; VISCOELASTIC: Z-HYALIN.
• Patient Sex: Male