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

Model Number	CCA0T0
Medical Device Problem Codes	Material Deformation (2976); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during cataract intraocular lens (iol) implant procedure, noted tip of device was bent.Lens unable to be safely placed in eye with device.There was no patient harm.Additional information was requested.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was returned for analysis and the reported complaint was observed.The device was returned in an opened blister tray.The lock-out assembly has been removed.Ophthalmic viscosurgical devices (ovd) is observed in the device.The plunger and lens are advanced to between mid-nozzle and the nozzle tip.The plunger is advanced partially over the lens.The plunger is bent, this typically occurs when the plunger is continuously advanced by pressing the lever but is blocked by the lens.The lens is crushed and misfolded.The nozzle has been removed from the lens bay and is hanging on the advanced plunger.The nozzle tip is bent/damaged.The nozzle was removed and cleaned for further evaluation.The tip has been bent/crushed.The end of the tip is split on the top.The lens was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results for the presence of top coat scrape marks were observed on the top and right where plunger impacted the tip.Reviewed photos and concurred related to the damage.We are unable to determine the root cause for the reported complaint.The nozzle tip was bent.The direction for use (dfu) instructs to inspect the company device nozzle before use, inspect device nozzle for damage, particulates, or deformation.Ensure that device is completely intact and that the plunger and lock-out assembly have not been moved.If the device does not pass the inspection criteria, use another company intraocular lens (iol) and company device delivery system.All company devices are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Plunger showed a slight override that resulted in lens becoming blocked/stuck in the device.Topcoat dye stain testing was conducted with acceptable results for the presence of top coat.Scrape marks were observed on the top and right where plunger impacted the tip.Plunger override was observed.Plunger override may occur - if the lens has become misaligned in the lens bay during the manufacturing process.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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 (more than 23 degree celsius / 73-degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.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 ASPHERIC UV ABSORBING IOL WITH 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: 20742902
• Report Number: 9612169-2024-01208
• Device Sequence Number: 8483585
• Product Code: HQL
• UDI-Device Identifier: 00380652397254
• UDI-Public: (01)00380652397254(17)271031(11)231102(10)25741858
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: CCA0T0
• Device Lot Number: 25741858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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
• Patient Sex: Unknown