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

Model Number	NGP680301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Eye Burn (2523)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a thermal injury to the cornea occurred during a surgical procedure.The incident involved dr.(b)(6) who experienced a phaco burn and used a suture to close the incision.The event log suggests that the surgeon may have mistakenly believed he was on the quadrant setting but was actually on the sculpt setting.This caused the healon 5 in the eye to plug the phaco tip, resulting in insufficient vacuum and tip heating.Following the incident, the patient was re-evaluated and found to have an intraocular pressure of 12, with edema limited to the incision area, a clear central cornea, a formed chamber, and improving vision.No further information provided.This is report 1 of 4.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as system is not an implantable device.Section d6b: if explanted, give date: not applicable, as system is not an implantable device.Section h3: the system 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.
Additional Manufacturer Narrative
Section b3: in the initial report the date of event was reported as dec 12, 2024, however, the correct date is dec 9, 2024.Section b4: in the initial report the date of this report was reported as jan 3, 2025, however, the correct date is jan 6, 2025.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes section h3.Device evaluated by manufacturer? yes product evaluation was performed for this incident.Device failed to function as intended, part replaced.Component failure is the probable cause.Manufacturing deficiency not identified, system met all specifications prior to release.Service deficiency not identified, no anomalies noted.Design deficiency not identified, no apparent design issues.No user/usage deficiency identified, no apparent issue.The risks and mitigations associated with the complaint issue are identified in existing risk or labeling documents and no new issues/risks were identified as part of this investigation.A search revealed that no additional complaints were received for this handpiece.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Corrected data: in reviewing the initial mdr, it was noticed that the manufacture date section h4 was inadvertently submitted incorrect.Therefore, it is captured in this supplemental report: section h4.Manufacture date: nov 19, 2019.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: 21085811
• Report Number: 3012236936-2025-000003
• Device Sequence Number: 6832382
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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?: No
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 03/05/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/06/2025; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2019
• 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: PHACO HANDPIECE, PHACO TIP, HEALON 5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown