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

Model Number	NGP680300
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, in phacoemulsification mode, the following system error occurred: error 374 "handpiece removed during phaco".No further information was provided.
Additional Manufacturer Narrative
Section a2 and a4: unknown, as information was requested but not provided.Section e1 - first/given name: unknown, as information was requested but not provided section e1 - telephone number: (b)(6).Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: h4 device manufacture date: in initial report, the manufacturer date provided was inadvertently reported as july 6, 2009, however the correct date is july 13, 2009.Additional information: section d9 - device available for evaluation? yes.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the service engineer checked and confirmed reported issue due to handpiece fault.A handpiece replacement was required.No issue found for system, it was performing to specification.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.07/13/2009.

• Brand Name: WHITESTAR SIGNATURE
• 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: 19712010
• Report Number: 3012236936-2024-000185
• Device Sequence Number: 8604495
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian