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

Model Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a capsule rupture occurred during a procedure.Through follow up we learned that the capsular rupture occurred intraoperatively while the patient was undergoing phacoemulsification using a signature pro device prior to intraocular lens (iol) implantation.The team reported the rupture was attributed to patient movement.An anterior vitrectomy was performed and a secondary implantation of an ar40e intraocular lens was completed.No additional details were provided.Note: this report is for the phaco system.Separate reports will be submitted for the phaco handpiece and phaco tip.
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 d4 - model #: unknown as product serial number was not provided.Section d4 - serial#: unknown/ not provided.Section d4 - expiration date: unknown as product serial number was not provided.Section d4 - udi #: a partial number was provided as the serial number was not provided.Section e1 - (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.Section h4 - device manufacture date: unknown as the serial number was not provided.Attempts have 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.

• 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: 23769854
• Report Number: 3012236936-2025-000316
• Device Sequence Number: 15883663
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: No
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Sex: Unknown