MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS, INC. WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number NGP680300

Device Problems Difficult to Insert (1316); Priming Problem (4040)

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

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Intermittent prime and tune issues related to cassette insertion difficulty.

• Brand Name: WHITESTAR SIGNATURE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS, INC.; 1700 east st. andrew pl.; santa ana CA 92705
• MDR Report Key: 8631087
• MDR Text Key: 145767554
• Report Number: 8631087
• Device Sequence Number: 1
• Product Code: HQC
• 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: 05/10/2019,05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• 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: 05/10/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1