MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number SY60WF

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 07/03/2022

Event Type  malfunction  

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A non healthcare professional reported during an intraocular lens implant procedure, the lens was inserted into the eye and subsequently explanted due to a small fracture/tear at the junction of the optic and trailing haptic.The small tear was at approximately the 7 o¿clock position, which is close to the point at which the plunger would contact the trailing aspect of the iol.Additional information has been requested.

Manufacturer Narrative

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

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15129397
• MDR Text Key: 296902893
• Report Number: 1119421-2022-01660
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

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: SY60WF
• Device Catalogue Number: SY60WF.125 CLAREON
• Device Lot Number: 15258084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1