MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE PRO; UNIT, PHACOFRAGMENTATION

Model Number NGP680301

Device Problems Failure to Prime (1492); Suction Problem (2170); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

Additional narrative information: unknown/ not provided.Date of event is unknown/ not provided.Serial number#: unknown/not provided.Expiration date: unknown as product serial number was not provided.Udi #: a complete udi # is unknown as product serial number was not provided.Device manufacture date: unknown, as the serial number of the device was not provided.Telephone number: (b)(6).Device evaluation: there was no service performed.Since the system serial is unknown, the complaint history data for individual system could not be performed.Since serial number is unknown a manufacturer record review related to the device including device history record could not be performed.A review of the device history record (dhr) could not be reviewed since the serial number was unknown.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that capsule rupture occurred during phaco procedure that required vitrectomy.The vitrectomy cutter failed to work to treat capsule rupture.There was no compressor and cutter movement sounds during priming and the vitrectomy cutter did not work when surgeon stepped on footpedal, vacuum error was displayed.The system was rebooted and vitrectomy cutter was replaced, however the same vacuum error kept occurring.Reportedly surgeon decided to use back up phaco machine from another manufacturer and the procedure was successfully completed with 180 minutes delay.There was no patient injury.The vitrectomy cutters were discarded at customer site.Patient is recovering.No further information provided.

• Brand Name: WHITESTAR SIGNATURE PRO
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15818011
• MDR Text Key: 303893676
• Report Number: 3012236936-2022-02848
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NGP0025, OPO73, ELLIPS FX HANDPIECE
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male