MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS WHITESTAR SIGNATURE SYSTEM; PHACOFRAGMENTATION

Model Number NGP680300

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Eye Burn (2523)

Event Type  Injury  

Event Description

An amo company representative reported that a surgeon at the surgery center had cases of corneal tissue adjacent to the main incision sustained a thermal injury during sculpting of a cataract procedure.The surgeon uses viscoat in the beginning of the case.There was a usually a plume of ¿milk¿ just before the thermal burn occurred.The surgeon indicated all were dense cataracts.An amo representative visited the account for follow up and to provide training to the surgeon.The amo representative wanted to confirm the surgeons setting believing if the aspiration and/or vacuum were too low, it can dramatically affect the phaco tip temperature.The amo rep indicated if he was able to reduce the temperature by incorporating a hyper pulse.The surgery center indicated they did not know which handpiece was used when the 3 corneal burns occurred over a 3-4 week period.The 3 cases occurred during the sculpt mode.This is three of three reports.Patient information was not provided, only that all 3 patients are fine.

Manufacturer Narrative

Patient information was not provided therefore it is unknown.Date of the event is unknown as it was not provided.An abbott medicals optics¿ phaco specialist visited the site.An amo representative reviewed the phaco settings and aspiration and stated most likely that the issue is that the surgeon uses dispersive ovd and then enters the eye to go into sculpt mode and the flow is only 15 and vacuum is 20.He increased the aspiration to 20 and vacuum to 30 and will incorporate the white star setting with an 8/2 duty cycle.This coupled with his plan to now clear a space above the lens to make sure he has flow before sculpting should eliminate the issue.The amo representative did not believe the handpiece or machine and likely is a pilot error.Further confirming that this is the fact that the other surgeon who operates there has had no issues.The surgery center indicated the patients are all doing fine.All pertinent information available to abbott medical optics has been submitted.Placeholder.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Type of Device: PHACOFRAGMENTATION
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 4749154
• MDR Text Key: 5770869
• Report Number: 3006695864-2015-00181
• Device Sequence Number: 1
• Product Code: HQC
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2009
• 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: ELLIPS HANDPIECE MODEL 690858, VISCOAT
• Patient Outcome(s): Other