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

Model Number CNA0T0

Device Problems Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem Iritis (1940)

Event Date 06/01/2022

Event Type  Injury  

Event Description

A physician reported that, following an intraocular lens (iol) implant procedure, something like dirt or a scratch was confirmed on the inside of the leading haptic even though the implant was performed safely.The foreign material was tried to be removed by irrigation and aspiration (i/a) but the dirt could not be removed, and it looked like a scratch and remained as it was.However the surgery was completed without product replacement.At the time of re-examination in mid-june, iritis had developed, and the washing of the anterior chamber was performed.It is probable that when i/a was attempted to remove the dirt/ scratch during the surgery, the leading haptic captured and came in contact with the iris which then developed iritis.The implant still remained in the patient's eye.Additional information was requested.

Manufacturer Narrative

A sample device was not returned for analysis, the lens remained in patient's eye.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Video shows iol(intraocular lens) implantation with company device.The device preparation is not recorded.Company nozzle comes in the picture.The lens appears to be in a correct position for the advancement.Mark/line is visible on the inner side of the leading haptic arm after implantation.What appears to be a partially adhered material is also observed at the same location.Not enough information provided on ovd(ophthalmic viscosurgical device) use and device preparation.No sample was returned for evaluation.Lens damage may occur: due to the use of a non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to underfill, overfill, misfolding , delivery issues and /or damage.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 and cause delivery issues and /or damage.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement and cause delivery issues and / or product damage.Any of the above listed causes alone, or in combination, may cause the damage to the lens.The origin of the observed material cannot be confirmed without the evaluation of the physical sample.Based on these investigation findings, we are unable to verify if the product contributed to the 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 Description

Additional information was requested and received stating the iritis was resolved.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Type of Device: 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: 15113288
• MDR Text Key: 296689173
• Report Number: 9612169-2022-00355
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25298652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 02/20/2023
• Supplement Dates FDA Received: 10/19/2022; 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVD- OPEGAN HI
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female