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 Codes	Capsular Bag Tear (2639); Zonular Dehiscence (2698)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.Phaco system is not an implantable device.Section d6b - explant date: not applicable.Phaco system is not an implantable device; therefore, not explanted.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 records including device history and complaint trending 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.
Event or Problem Description
It was reported that, during a surgical procedure using the signature pro machine, the device went completely black and turned off during the chop stage.A few seconds later, the machine restarted on the same screen, but the surgical team had to prime and tune the tubings again.As a result of the device issue, there was a collapse of the eye and a small rupture, which required a vitrectomy.From event log: 6983b0eb (b)(6) 2026 / 12:49:47 353 353 ih to gui communication error.The patient recovered after surgery, it was reported that it was a difficult patient from the beginning, but the surgeon's skills saved any future issues.The procedure was delayed by 5¿10 minutes.Through follow up we learned the posterior capsule was ruptured.No details available for the tubing pack, handpiece and needle.There was no material available for further investigation.No further information was provided.
Additional Manufacturer Narrative
Correction: the service was completed on 3rd march.This information was inadvertently left out of the initial mdr (b)(4) report filed on 4th march.Device evaluation: service checked and confirmed the reported issue.The monitor pivot and cables were replaced.The system is performing to specification.Section h4 - device manufacture date: in initial report, the manufacturer date provided was inadvertently reported as 03/31/2015, however the correct date is 04/20/2016.Additional information: section d9 - device available for evaluation? yes.Section h3 - device evaluated by manufacturer? yes.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 24508356
• Report Number: 3012236936-2026-000039
• Device Sequence Number: 9870234
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/29/2026

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
• Was Device Available for Evaluation?: Yes
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TUBING PACK, HANDPIECE, TIP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown