MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE SYSTEM; PHACOFRAGMENTATION UNIT

Model Number NGP680300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Swelling (2091)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Manufacturer year: 2008.The phacoemulsification machine and suspected handpieces were examined and tested at the customer location by a j&j field service specialist (fss).The suspected handpieces were evaluated and tested.The handpieces were found to be within specifications.The fss found no issues with the operation of the equipment.A preventative maintenance was performed.The fss performed a field service checklist.The fss provided training awareness and guided on good equipment handling practices for use of tubing packs unrelated to the event.The system was verified for all modes of operations.The system met all factory specifications.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A hospital reported a cataract patient experienced cornea edema.It was reported the patient experienced corneal swelling and loss of 2 lines of best corrected visual acuity after the surgery.The patient was treated with medication to treat the swelling.The treating surgeon was not sure what contributed or caused the edema, but as a precautionary, requested the phacoemulsification equipment and two of the phaco handpieces evaluated.The surgeon also considered other factors may have contributed to the event.It is unknown which two handpieces were used for each patient; proactively reporting on both handpieces.This report is for the phacoemulsification equipment.A separate report will be submitted for each handpiece.

Manufacturer Narrative

Additional information: the treating surgeon confirmed his technique caused the reported issue as the straight tip was changed from a curve tip.The patient outcome results are good.In initial report, the manufacturer year was only provided, however the full date is 11/24/2008.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Type of Device: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8892563
• MDR Text Key: 154257878
• Report Number: 3006695864-2019-00660
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDPIECE SERIAL NO. (B)(6); HANDPIECE SERIAL NO. (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR