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

Model Number 0180-1201

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

The laser failed to recognize the disposable lens stating error message: disposable lens not present despite re-applying disposable lens.Another device was opened to complete the procedure.Failed lens 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: 12099663
• MDR Text Key: 259431472
• Report Number: 12099663
• 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: 0180-1201
• Device Catalogue Number: 0180-1201
• Device Lot Number: 13743390
• 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: 29930 DA