MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ACRYSOF ULTRASERT; INTRAOCULAR LENS

Model Number AU00T0

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

The haptic from this lens was not coming out properly and doctor tried to manipulate without success.

• Brand Name: ACRYSOF ULTRASERT
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 12646578
• MDR Text Key: 276875102
• Report Number: 12646578
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0V300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 79