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

Model Number NGP680301

Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

An unspecified issue requiring unplanned vitrectomy was reported.The surgeon performed an unplanned vitrectomy.It was also indicated that during the vitrectomy procedure, chamber instability was experienced due to incorrect size of infusion cannula.The procedure was completed using a backup equipment.No additional information is available at the time of this report.

Manufacturer Narrative

Correction: in the initial report it was stated that the code 4581 was for the unplanned vitrectomy however, this is not correct as the code was for the shallowing of the anterior chamber.The code for the unplanned vitrectomy used int he initial report under the health effect was 4624 but the correct code is 4625.

Manufacturer Narrative

Section h6: corrected data.Section h6: medical device problem code as part of an internal review of our mdrs it was identified that the code 3023 for ( vitrectomy mode issues) was not provided on the initial report.This report is being submitted to include code 3023.Section h6: component code added: 4707.

• 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 ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 11581963
• MDR Text Key: 242718998
• Report Number: 3006695864-2021-07414
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• 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: 10/20/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 09/01/2022; 10/19/2022
• Supplement Dates FDA Received: 09/27/2022; 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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