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

Model Number NGP680301

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

It was reported that the customer experienced an issue with the foot pedal irrigation becoming stronger with progressive foot pedal depressions.Through follow up we learnt that a capsule breakage occurred due to the irrigation problem.According to reports, irrigation started late and then increased suddenly with the progression of the pedal causing instability.The patient is fully recovered and daily activities are not significantly affected.A vitrectomy was required and no other surgical or medical interventions were reported.No additional information was provided.

Manufacturer Narrative

Per regulation (eu) 2016/679 (general data protection regulation), patient identifiers should not be collected or recorded or shared with any third parties; therefore the information is not provided.Telephone number: (b)(6).Device evaluation: the field service engineer evaluated the system in the presence of the customer and was not able to reproduce the issue.The system was working within specifications and the reported issue could not be confirmed.Customer has been asked to monitor the behaviors of the food pedal.Manufacturing record evaluation: the manufacturing records of the system were reviewed.The product was manufactured and released according to specification.A search revealed that one additional complaint for footpedal issues and 1 reports of irrigation issue during procedure were received for the whitestar signature pro system.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 13560700
• MDR Text Key: 296388287
• Report Number: 3012236936-2022-00352
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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