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

Model Number AU00T0

Device Problems Device Difficult to Setup or Prepare (1487); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2018

Event Type  malfunction  

Event Description

Incorrectly loaded in preloaded assembly- haptic protruding from end of cartridge.

• 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: 9238952
• MDR Text Key: 163796711
• Report Number: 9238952
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AU00T0
• Device Lot Number: 12617487101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1