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

Model Number CCA0T0

Device Problem Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2024

Event Type  malfunction  

Event Description

A healthcare professional reported that, during intraocular lens implantation surgery, after injection of the lens into the lens capsule, the physician noticed a blue colored filament or strand adhering to the lens.The physician stated that blue color is similar to the lock out assembly and plunger.Additional information has been requested, but no further information is available.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that, during intraocular lens implantation surgery, after injection of the lens into the lens capsule, the physician noticed a blue colored filament or strand adhering to the lens.The physician stated that blue color is similar to the lock out assembly and plunger.Additional information has been requested, but no further information is available.Additional information has been received and stated that foreign body material was removed in initial procedure, there was no patient harm but did need to manipulate and go in the bag in a patient with weak capsular bag and there were no patient issues.

Manufacturer Narrative

The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.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
• 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: 18811831
• MDR Text Key: 336985555
• Report Number: 9612169-2024-00163
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CCA0T0
• Device Lot Number: 25668328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.12 FORCEPS; AMVISC
• Patient Age: 68 YR
• Patient Sex: Male