MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 690880

Device Problems Use of Device Problem (1670); Suction Problem (2170)

Patient Problems Corneal Abrasion (1789); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event 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 2/7/2023.Reportedly transconjunctival single plane sclercorneal incision method was used with 2.75 mm incision size.There was no incision widened.Surgeon will perform secondary surgery to remove fragments with irrigation aspiration and 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 treatment date was (b)(6) 2023.Removal of residual nuclear fragment (post-spherical anesthesia).Bimanual irrigation aspiration (ia) was used and aspirated while shattering nuclear fragments with the tip.Nuclear fragment was aspirated without problems.Doctor mentioned that the corneal endothelial cell was decreased (1700 in this eye, 2000 in one eye), probably because it was a relatively large nucleus fragment.No particular problems with vision.This event will capture information for 3 of 3 patients.Other reports are being submitted for other patients.

Manufacturer Narrative

Additional narrative information: section e1: telephone number: (b)(6).Section d4: serial number#: unknown/not provided.Section d4: expiration date: unknown as product serial number was not provided.Section d4: udi #: a complete udi # is unknown as product serial number was not provided.Section h4.Device manufacture date: unknown, as the serial number of the device was not provided.Device evaluation there was no service performed.Since the system serial is unknown, the complaint history data for individual system could not be performed.Since serial number is unknown a manufacturer record review related to the device including device history record could not be performed.A review of the device history record (dhr) could not be reviewed since the serial number was unknown.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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: ELLIPS FX PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16686984
• MDR Text Key: 312756063
• Report Number: 3012236936-2023-00817
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981116
• 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,Followup
• Report Date: 05/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/19/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian