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

Model Number	NGP680301
Medical Device Problem Codes	Use of Device Problem (1670); Suction Problem (2170); Application Network Problem (2879)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer found nuclear fragments remained in the anterior chamber during the post exams.Surgeon perceived that the vacuum performance during irrigation aspiration and phaco mode was bit low.The issue had occurred in three procedures since after the machine was checked on (b)(6) 2023.Reportedly transconjunctival single plane scleracorneal incision method was used with 2.55 mm incision size.There was no incision widened.Irrigation, suction, and removal with irrigation aspiration is planned for end of (b)(6) 2023.Patient was prescribed with medication (levofloxacin, sanbetason).The patient outcome was reported as good visual acuity with no problems.The pack was reused for the patient.Additional information was received, and it was learnt that on (b)(6) 2023 there was removal of residual nuclear fragments performed using ophthalmic anesthesia.Surgeon aspirated by using a bi-manual irrigation aspiration (ia) while shattering nuclear fragments with the tip.Nuclear fragments were aspirated without problems.There was descemet's fold that seemed to be caused by an effect of the bi-manual ia operation.As a result, visual acuity decreased from 0.9 to 0.6, but according to the doctor, it is likely to recover gradually.This event will capture information for 1 of 3 patients.Other reports are being submitted for other patients.No further information was provided.
Additional Manufacturer Narrative
Additional narrative information: telephone number: (b)(6).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: at the time of initial filing following health effect impact code and clinical code was inadvertently missed, hence this is being added.Section h6: health effect-impact code ¿ 4625 for secondary surgical intervention: surgical intervention section h6: health effect-clinical code ¿ 1789 for striae in descemet's: corneal striae.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO
• 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: 16687002
• Report Number: 3012236936-2023-00808
• Device Sequence Number: 12611779
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian