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

Model Number NGP680301

Device Problem Mechanical Problem (1384)

Patient Problems Eye Injury (1845); Corneal Clouding/Hazing (1878); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

Additional narrative information: age at time of event: unknown.Date of birth and gender: unknown.Patient weight: unknown.Ethnicity and race: unknown.Telephone number: (b)(6).A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during procedure, it was unable to stop aspiration and irrigation, when the footpedal was released.It was unable to activate backflush.As a result, the anterior chamber became unstable, however, there was no posterior capsule rapture.Doctor switched the footpedal from wireless to wired mode and rebooted, however, the issue was not resolved.It got a pedal error like "it's still being pressed".Then, customer detached and reattached all equipment, tried it from the beginning, and the machine started working, and procedure was successfully completed with 60 minutes delay.Anterior vitrectomy cutter was used to treat.Additional information was received, and it was learnt that visual acuity of the patient decreased from 0.05 (pre-op) to 0.02 (post op).It was also diagnosed that patient had bullous keratopathy and decreased corneal endothelial cell.Reportedly subconjunctival injection of dexart was given for inflammation to subside.No further information provided.

Manufacturer Narrative

Correction data in the initial mdr the component code was inadvertently not populated.Section h6: component code - 819 - foot pedal.Additional information: device evaluation: service was completed and product evaluation was performed for this incident.Device failed to function as intended during functional testing performed by service.Foot pedal was replaced.No product deficiency was identified.Section h6: investigational findings: 3248 - wireless communication problem.Section h6: investigational conclusions: 4307 - cause traced to component failure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO
• Type of Device: 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: 16968516
• MDR Text Key: 315672122
• Report Number: 3012236936-2023-01268
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention