MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE; ULTRASONIC SURGICAL SYSTEM TUBING SET

Model Number	OPO73
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure, using the whitestar signature pro system, a challenging case involving a patient with glaucoma was encountered.The surgeon faced difficulties due to the patient's pupil not dilating and a shallow chamber.Despite considering stopping the procedure, he decided to continue, which led to complications with a floppy iris that prolapsed through the corneal incision.The incision was enlarged and sutures were required.An unplanned vitrectomy was performed, and the vitrectomy cutter functioned as expected.However, the surgeon was unable to implant the intraocular lens (iol) and opted to recall the patient for a future procedure using a three-piece iol.
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 h4 - device manufacture date: unknown as product serial number was not provided.Section h6 -health effect - clinical code: 4581: incision enlarged section h10 - phaco handpiece with unknown lot number, phaco tip with unknown lot number and whitestar signature pro system sn (b)(6).Section e1 - telephone number: (b)(6).Additional information: through follow up we learned that the surgeon believed bubbles in the tubing contributed to the vitrectomy.They also reported that the bubble may have occurred due to the handpiece not being at 45 degrees at prime and tune.They also reported that a procedure afterward was uncomplicated.No further information was provided.Device evaluation: at the time of the investigation, product was not available for evaluation.Therefore, no testing could be performed.Lot number was not provided and manufacturing record review could not be performed.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.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: ULTRASONIC SURGICAL SYSTEM TUBING SET
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21657894
• Report Number: 3012236936-2025-000068
• Device Sequence Number: 8226020
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160236
• 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: Other Health Care Professional
• Type of Report: Initial
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: UNKNOWN
• 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: 02/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown