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

Model Number	CNA0T0
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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).
Event or Problem Description
A health care profession reported that during a cataract surgery with an intraocular lens (iol) implant procedure trailing haptic folded wrong, as it was stuck under the iol once delivered in the capsular bag.Surgeon had difficulty unsticking it beneath.The procedure completed on the same day.Additional information received stating trailing haptic stuck to optic.
Event or Problem Description
Additional information received stating trailing haptic stuck to optic.Lens was left implanted.There was no patient harm.
Additional Manufacturer Narrative
Corrected information was provided in b5 and h6.On initial mdr submitted the fda patient codes should be e2403 instead of e2401, fda health impact codes should be f26 instead of f24 and eval method codes should be b20 instead of b17.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care profession reported that during a cataract surgery with an intraocular lens (iol) implant procedure trailing haptic folded wrong, as it was stuck under the iol once delivered in the capsular bag.Surgeon had difficulty unsticking it beneath.The procedure completed on the same day.Additional information received stating trailing haptic stuck to optic.Lens was left implanted.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.It was reported that haptic was observed to be stuck to the optic after implantation.The root cause of the reported issue is deemed to be related to manufacturing process change that increased the likelihood of company iol haptics adhering to the posterior optic surface following delivery with the company device.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 22496130
• Report Number: 9612169-2025-01382
• Device Sequence Number: 20604714
• Product Code: HQL
• UDI-Device Identifier: 00380652396516
• UDI-Public: (01)00380652396516(17)270409(11)240410(10)25829136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

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: 25829136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 09/04/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/26/2025
• Date Device Manufactured: 04/10/2024
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown