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

Model Number NGP680300

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that bottle hanger and foot pedal is damaged.It was reported that there was no patient involvement.No other information was provided.

Manufacturer Narrative

Age or date of birth, weight and ethnicity: information unknown/ not provided, 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).Health care professional: unknown/not provided.Occupation: unknown/not provided.Device evaluation: the whitestar signature pro was made available for evaluation as an field service engineer ( fse ) went on site.The system was found within specification.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.

• 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: 14287766
• MDR Text Key: 290811216
• Report Number: 3012236936-2022-01057
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2008
• 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