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

Model Number	NGP680300
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6b - explant date: not applicable, lens remains implanted, therefor not explanted.Section e1 - telephone number: (b)(6).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.
Event or Problem Description
It was reported that during continuous curvilinear capsulorhexis the error code e148 appeared with the following message "cutting pressure is being applied" and the pump operation sound continued.After multiple restarts were performed, the pump sound stopped once and then error code e126 appeared.The surgery was halted midway, and the patient was transported to a hospital.On the same day, an emergency surgery was performed at the hospital to implant the intraocular lens without any problem.After surgery the patient visited the clinic without any problems and visual acuity was maintained at 1.0.
Additional Manufacturer Narrative
Correction: section h4: in initial report, the manufacturer date provided was inadvertently reported as jun 28, 2010, however the correct date is july 16, 2010.Additional information: section d9 - device available for evaluation? yes.Section h3 - device evaluated by manufacturer? yes.Device evaluation: there was no malfunction.An alarm triggered and presented the following errors [148-fluidics pack pressure error and 126-fluidics motor vent error].Adjustments were made but no parts replaced.Probable cause: user settings/calibration [tube reattached].A manufacturing deficiency was not identified, the system met all specifications.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.
Additional Manufacturer Narrative
Corrected information: initially the code clinical code 4607 - pt- hospitalization was added to the complaint file, however the code is not applicable and it was removed since the patient did not have a overnight stay at the hospital.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: 20873219
• Report Number: 3012236936-2024-000314
• Device Sequence Number: 15626751
• 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,Followup
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 02/17/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/30/2024; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male