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

Device Problems Complete Blockage (1094); Fire (1245); Mechanical Problem (1384)

Patient Problem Eye Burn (2523)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter - phone number : (b)(6).Brand name is unknown as the serial number was not provided.Model number is unknown as the serial number was not provided.Unique identifier is unknown as the serial number was not provided.Manufacturer date is unknown as the serial number was not provided.The clinic is reporting this adverse event only and did not request or require field service or clinical support.No evaluation could be performed as the product was not returned.The serial number of handpiece was not provided; therefore, the manufacturer record review could not be performed.All pertinent information available to (b)(4) has been submitted.

Event Description

Corneal burn occurred when surgeon started the surgery, when doing a debulk, before sculpting.Surgeon used a bit of phaco then and saw a bit of smoke and she knew the handpiece was probably blocked (competitor's viscocoat was used).She removed the handpiece from the patient's eye and put it in a cup of balanced salt solution (bss) and continued the surgery with no further problem.Six sutures were needed at the conclusion of the procedure.No issues or medication needed outside of the sutures.Patient is doing well.

• Brand Name: UNK_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: 11402355
• MDR Text Key: 234370652
• Report Number: 3006695864-2021-07286
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• 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: WHITESTAR SIGNATURE PRO CONSOLE
• Patient Outcome(s): Required Intervention