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

Model Number NGP680300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Decompensation (1790); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported that during surgery the physician had some difficulty to maintain a stable chamber.Through follow up we learned that after hydrodissection and initiating of the phacoemulsification with the introduction of the needle, there was no anterior chamber formation that would allow a normal course of surgery.Whenever the pedal was pressed, the chamber did not form and, with the vacuum, it collapsed.All the equipment parameters were in accordance with the standard and recommended.Initially, the handpiece and needle, and later the fluidic were unsuccessfully replaced.The surgeon was able to complete the procedure by using ovd in large quantities.In the end, central anterior vitrectomy was necessary.With prolonged surgical time and insufficient anterior chamber, the patient had a longer and more difficult recovery with significant decompensation of the entire cornea.No further information has been provided.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Telephone number: (b)(6).Device evaluation: the field service engineer (fse) was on site after the event and completed a system checkup.Fse could not duplicate the reported issue.A review of the records related to the device was performed.The system and its components met all specifications prior to being released.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
• 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: 14058437
• MDR Text Key: 298516712
• Report Number: 3012236936-2022-00899
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2011
• 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