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

Model Number NGP680301

Device Problem Mechanical Problem (1384)

Patient Problem Eye Injury (1845)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Unknown/ not provided.Serial number: unknown/not provided.Catalog#: unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi number: a complete udi # is unknown as product serial number was not provided.If implanted, give date: not applicable, as the phaco system is not implantable device.Section d6b: if explanted, give date: not applicable, as the phaco system is not implantable device.Device manufacture date: unknown as product serial number was not provided.Other (81): the phaco 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.

Event Description

Customer reported that they had to do a vitrectomy on a patient and when they started, the vitrector was not cutting or aspirating.They lowered the cutting settings on the whitestar signature pro and it seemed to work a little.Through follow up it was reported by the account that the vitrectomy was unplanned.It was not reported what caused it.

Manufacturer Narrative

Correction: initial submission was submitted as an unknown lot number but it should have been lot number 60399739.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

It was reported that the devices were discarded and should not be expected.No further information was provided.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: 18531756
• MDR Text Key: 333086090
• Report Number: 3012236936-2024-00129
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

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
• Device Lot Number: 60399739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 03/27/2024
• Supplement Dates FDA Received: 03/20/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VITRECTOMY CUTTER LOT #60399739.
• Patient Outcome(s): Required Intervention