MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNA0T5
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2025
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 nurse reported that during the intraocular lens (iol) implant procedure, noticed problems with the unfolding of the two haptics of the lens.Lens remained in the eye.Additional information has been requested.
Additional Manufacturer Narrative
Correction information was provided in h.6.On initial medical device report (mdr) the fda evaluation codes of b.17 was submitted.It should have been b.20, and fda product problems codes of a2201 was submitted.It should have been a040604.Additional information was provided in h.11.The product was not returned for analysis.The complainant indicates the use of viscoelasticum 2 percent as a viscoelastic, which is not qualified for use with associated model, this is not a qualified alcon product combination.The root cause for the reported complaint could not be determined.No product was returned for analysis.The surgeon states the use of non-qualified viscoelastic.The use of an unqualified ophthalmic viscosurgical device (ovd) may cause damage to the lens and potential complications during the implantation process.Close adherence to the instruction for use (ifu) provides the best opportunity for optimal delivery.Possible associated factors may also include: 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 degrees centigrade (64 degrees fahrenheit) to 23 degrees centigrade (73 degrees fahrenheit).Ovd should be allowed to come to operating room temperature over a 20 minute timeframe prior to use.If the operating room temperature is too high (greater than 23 degrees centigrade / 73 degrees fahrenheit) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement.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 TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21992488
• Report Number: 9612169-2025-01018
• Device Sequence Number: 14518870
• Product Code: MJP
• UDI-Device Identifier: 00380652399906
• UDI-Public: (01)00380652399906(17)280825(11)240827(10)25897676
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: CNA0T5
• Device Lot Number: 25897676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 08/27/2024
• 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: UNSPECIFIED CARTRIDGE.; UNSPECIFIED INJECTOR.; VISCOELASTICUM 2 PERCENT.
• Patient Sex: Unknown