MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 690880

Device Problem Contamination (1120)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that foreign debris was seen inside the patient¿s operative eye.Event occurred shortly after he inserted the phaco tip into the eye.A brief description of the event indicated that the debris was white and looked like white styrofoam.It was stated that the debris was roughly spherical in shape with a diameter approximately 1mm (it was slightly larger than the diameter of the phaco tip which was one of our 21g tips).The surgeon was not able to aspirate it out just using vacuum so he applied a little ultrasound which allowed the system to aspirate most of it, but he noticed the ultrasound caused two very small pieces to break free and imbed themselves in the iris.The surgeon was unable to remove the debris.It was indicated that the ellips fx handpiece had been sitting on the shelf in a peel pack for approximately one year based on the dated sterilization label.No patient injury was reported.No further information was provided.This report is for the ellips fx handpiece.A separate report is being submitted for the laminar tip under 3012236936-2022-01673.

Manufacturer Narrative

Concomitant medical products: opohf21l, 60334477 sleeve, ellips fx handpiece s/n unknown, veritas advanced infusion pack, lot #60355024, model #vrt-ai.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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 relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been provided.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 14854434
• MDR Text Key: 303098047
• Report Number: 3012236936-2022-01726
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: UNK-ELLIPS FX PHACO HANDPIECE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VERITAS CONSOLE S/N VERITAS, 202110049