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

Model Number CNA0T0

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the iol was trapped in the injection device, which is why surgeon was forced to break the plastic capsule where the lens was located, which came out with a damaged haptic, however the doctor decided to implant the intraocular lens in the patient's eye.Additional information has been requested.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.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: 15834810
• MDR Text Key: 307704172
• Report Number: 9612169-2022-00627
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393713
• UDI-Public: 00380652393713
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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
• Report Date: 11/21/2022

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
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1