MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LAMINAR FLOW PHACO CVD TIP 45D 21G SL REUSE; PHACO ACCESSORY

Lot Number UNKNOWN

Device Problems Restricted Flow rate (1248); Obstruction of Flow (2423)

Patient Problem Eye Burn (2523)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Model no.Is unknown as it was not provided.Lot no.Is unknown as it was not provided.Unique identifier (udi#) is unknown as lot no.Was not provided.Manufacturer date is unknown as lot no was not provided.The phaco console and handpiece was evaluated by a field service engineer.The field service was not able to duplicate the issue.There were no issues found with the operation of the handpiece as it passed testing and met specifications.A field service checklist was performed.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During a cataract extraction procedure, a corneal burn occurred in the patient¿s operative eye.A description from the surgery center indicated during the capsulorrhexis, the surgeon switched to healon gv, a heavier viscoelastic due to something in the lens capsule.The surgeon proceeded to the phaco segment and there was a restricted irrigation flow that resulted in a small corneal burn.Afterwards, the handpiece was taken out of the eye.It was observed that the tip and sleeve was full of viscoelastic.The surgery center believes the viscoelastic clogged the tip and sleeve.The surgeon flushed out the tip and sleeve.The flushing loosened the viscoelastic and the surgeon ensured the tip and sleeve were free from the viscoelastic and the procedure was completed.In addition, it was indicated that prior to procedure commencing, the nurse had primed the handpiece successfully.There were no errors displayed or detected during the priming stage.After the flushing out the viscoelastic-healon gv, and completing the procedure, the handpiece was cleaned.There was no obstruction noted during the cleaning process.This report is for the tip/sleeve.Two separate report will be submitted for the handpiece and the healon gv.

Manufacturer Narrative

Additional information was provided about the event.The corneal burn did not require any medications for intra operatively in the eye.They use 20g reusable curved tips with a yellow sleeve and the incident occurred in quadrant removal after the addition of healon gv to the eye.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 nr-0148919 and capa: 010215.

• Brand Name: LAMINAR FLOW PHACO CVD TIP 45D 21G SL REUSE
• Type of Device: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9433549
• MDR Text Key: 169722276
• Report Number: 3006695864-2019-00950
• Device Sequence Number: 1
• Product Code: HQC
• 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: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: PHACO HANDPIECE AND HEALON GV; PHACO HANDPIECE AND HEALON GV
• Patient Outcome(s): Other