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

Model Number	NGP680300
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Corneal Decompensation (1790); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012236936-2022-00899
• Device Sequence Number: 4871635
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown