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

Model Number CNA0T0

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2023

Event Type  Injury  

Event Description

A physician reported that, during implantation, the doctor did not pay attention to the fact that the posterior haptic was bitten and the lens was implanted without it.The doctor did not immediately remove the iol from the eye and decided to observe.Now the doctor was talking about the decentration of the lens and was thinking about reimplantation and replacing the iol with a similar lens.Additional information has been requested and received stating that patient was re-implanted with an unknown intraocular lens.Therefore, the return of the iol was not possible.

Manufacturer Narrative

A sample device 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).

Manufacturer Narrative

Photo provided.Reported complaint cannot be confirmed from the provided photo.Based on our observation of the attached photo, the reported complaint cannot be confirmed from the provided photo.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 17676704
• MDR Text Key: 322601543
• Report Number: 9612169-2023-00629
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393805
• UDI-Public: 00380652393805
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25602091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female