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

Model Number	NGP680301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as the system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the system is not an implantable device.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.Citation: scott, r.A., holtmeyer, c.J., parker, t.M., scott, w.J., & olson, r.J.(2025).Comparison of venturi and peristaltic based phacoemulsification efficiency in routine femtosecond laser cataract surgery.Canadian journal of ophthalmology, 60(2), 85¿90.Https://doi.Org/10.1016/j.Jcjo.2024.07.012.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A single center, nonrandomized clinical study was done to compare the efficiency of venturi and peristaltic pump phacoemulsification systems in patients undergoing routine laser cataract surgery.A total of 995 eyes underwent routine laser cataract surgery (lcs) (521 eyes underwent lcs with venturi-based vacuum and 474 eyes underwent lcs with peristaltic vacuum).Each surgery was treated with a catalys laser system (johnson & johnson vision) (device in scope) and a whitestar signature pro phacoemulsification system (johnson & johnson vision).During the procedure, the lens was split into two hemispheres by ¿endolenticular viscodissection¿ (wjs) using healon (johnson & johnson) on a 30-gauge cannula or by a quick-chop technique along the central laser segmentation line.In the venturi group, intraoperative complications reported include posterior capsule break without vitreous loss (n=1 eye) and anterior capsule tear (n=2 eyes) while in the peristaltic group, intraoperative complications reported include posterior capsule break without vitreous loss (n=1 eye) and anterior capsule tear (n=1 eye).There were no clear distinction on which events were attributed to which device.There are no indications in the article of any interventions provided.Note: this is report 2 of 3.

• 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: 22470452
• Report Number: 3012236936-2025-000188
• Device Sequence Number: 7986248
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: NGP680301
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• 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: Other
• Patient Sex: Unknown