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

Model Number	NGP680301
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that phaco signature pro had an initial problem with the opo71 cassette and was not working properly.The cassette was then changed to the opo73, where the surgery was started correctly.Prime and tuned ok and during the first surgery the phaco showed a lot of surges, rupturing the capsule and requiring intervention with vitrectomy.Lens was implanted and doctor will monitor and evaluate progress in postop.No additional information has been provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/ 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 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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: h4: in initial report, the manufacturer date provided was inadvertently reported as jan 9, 2019, however the correct date is jan 23, 2019.Additional information: device evaluation: during the evaluation, errors 149 and 503 were identified, caused by a defect in part solenoid/str gauge.Therefore, it was necessary to replace it.After replacing the part, all tests were successfully conducted.Additionally, preventive maintenance was also carried out.System is performing to specifications.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.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: 19522872
• Report Number: 3012236936-2024-000165
• Device Sequence Number: 8412272
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151636
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: NGP680301
• Device Catalogue Number: NGP680301
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2019
• 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: OPO73
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female