MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS WHITESTAR SIGNATURE SYSTEM

Model Number NGP680300

Device Problems Use of Incorrect Control/Treatment Settings (1126); Increased Pump Speed (1501); Increase in Suction (1604)

Patient Problem Eye Injury (1845)

Event Date 07/24/2014

Event Type  Injury  

Event Description

A surgeon reported during a cataract extraction procedure, a patient injury occurred when the iris was drawn into the phaco tip.The surgeon indicated that it is possible he inadvertently selected the incorrect phaco submode settings.He may have chosen the quad mode settings believing it to be using the peristaltic pump during the sculpt stage which increases the vacuum from 15mmhg to 120mmhg, the surgeon suspected the increase in vacuum may have caused the iris to be drawn despite the phaco tip was within the capsular bag as well as the patient may have had a very floppy iris; however not confirmed.Additional information was received indicating during the procedure, the surgeon had requested an increase in phaco power and instead vacuum was increased pulling iris into the tip.Subsequently, the patient experienced iris damage and as a result the patient has a hole in the iris.Although not confirmed, the surgeon stated the device was incorrectly prepared for use and eye anatomy was the probable cause that contributed to the patient injury.

Event Description

The hospital clarified the patient has permanent damage but no damage to visibility was suggested.

Manufacturer Narrative

Patient information was not provided.The phacoemulsification machine was examined and tested at the customer location by an abbott service technician and the technician was not able to duplicate the reported event.A field service checklist was performed and the event and error logs for the unit were reviewed.The vacuum was checked and tested.The customer was provided with training awareness.The system was verified for all modes of operations and calibrations.The machine was found to meet amo specifications.All pertinent information available to amo at the time of this report has been submitted.Placeholder.

Manufacturer Narrative

In initial report, other was selected at the time of review of information.Additional information has been provided to include disability or permanent damage as described by the hospital for outcomes attributed to adverse event the hospital provided information in which the serious injury was permanent.All pertinent information available to abbott medical optics at the time of this report has been submitted.Placeholder.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Type of Device: SIGNATURE
• 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: 4032352
• MDR Text Key: 4806107
• Report Number: 3006695864-2014-00388
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• 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: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2010
• 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
• Patient Outcome(s): Other; Disability