MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIQUID OPTICS INTERFACE; OPHTHALMIC FEMTOSECOND LASER

Model Number 1080-1201

Device Problems Device Displays Incorrect Message (2591); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

Failure to lock error stating vacuum error.Kink noted in lower tubing of suction ring.Another loi was opened to complete the procedure.Product had patient contact but no patient harm.

• Brand Name: LIQUID OPTICS INTERFACE
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 12099662
• MDR Text Key: 259431542
• Report Number: 12099662
• Device Sequence Number: 1
• Product Code: OOE
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1080-1201
• Device Catalogue Number: 1080-1201
• Device Lot Number: 13457318
• 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: 06/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA