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

Model Number	NGP680301
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system shuts down intermittently during surgery.There was no information if they were able to complete the procedure during the same visit.No patient injury was reported.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section d6a: implant date: not applicable as this is not an implantable device.Section d6b: explant date: not applicable as this is not an implantable device.Section e1: initial reporter first & last name: unknown/information not provided.Section e1: email address: unknown/information not provided.Section e1: telephone number: unknown/not provided.Section h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO
• Common Device Name: 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: 17146518
• Report Number: 3012236936-2023-01516
• Device Sequence Number: 5744524
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown