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); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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.Provided photo shows an iol on unknown background.One haptic appears to be broken and not present.The iol optic appears to be cracked and chipped.The investigation conducted a nonconformance review of the reported lot number.No deviations were identified, and all corresponding production release specifications defined in the device master record were met.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported during intraocular lens (iol) implant procedure; the haptic defect was detected after implanting the lens.The lens was explanted and replaced with similar lens during initial procedure without any patient harm.Current condition of the patient was satisfactory.Additional information has been requested and received stating that one haptic was missing after implantation.
Additional Manufacturer Narrative
Additional information was provided in h.11.The product was not returned for analysis.Only photo was returned.Provided photo shows an intraocular lens (iol) on unknown background, outside of the company device.Only part with the label of the company device is visible in the photo, the rest of the device is not captured in the photo.One haptic appears to be broken and not present.The iol optic appears to be cracked and chipped.We are unable to determine the root cause for the reported complaint "haptic defect detected/one haptic missing after implantation".The product was not returned for analysis.Damage to the iol and to one haptic was observed in the returned photo.Broken haptics may occur: due to the use of a non-qualified viscoelastic.Material properties of non-qualified ophthalmic viscosurgical devices (ovds) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the reported event.A final root cause cannot be determined based on available information and without the evaluation of the physical product.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that during lens implantation, when part of the lens had already been inserted, it was discovered that the haptic had gotten stuck in the cartridge and had come off.The damaged lens was removed and replaced with a new one during initial procedure.The planned operation was successfully completed.The patient was discharged without any complications or side effects.Patient condition was satisfactory, no complaints, and was satisfied with the result of the operation.
Additional Manufacturer Narrative
Additional information was provided in b.5.And h.6.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: 21718483
• Report Number: 9612169-2025-00492
• Device Sequence Number: 9590678
• Product Code: HQL
• UDI-Device Identifier: 00380652393805
• UDI-Public: (01)00380652393805(17)270225(11)240227(10)25804126
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Followup
• Report Date (Section B): 06/20/2025

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: 25804126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 05/27/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/01/2025; 06/20/2025
• Date Device Manufactured: 02/27/2024
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown