MAUDE Adverse Event Report: ALCON RESEARCH, LLC CATARACT IMPLANT; INTRAOCULAR LENS

Model Number SY60WF

Device Problems Defective Device (2588); Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 03/06/2023

Event Type  Injury  

Event Description

Cataract surgery- foreign object of unknown origin introduced during implantation of iol (intraocular lens).Product defect.The implanted lens had to be cut and removed followed by a new lens implant.

• Brand Name: CATARACT IMPLANT
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 16876900
• MDR Text Key: 314740377
• Report Number: MW5117263
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention