FDA Adverse Event Injury Summary report: N

INTRALASE

MDR report key: 2955904 · Received February 11, 2013

Report

Report Number: 2648035-2013-00086
Event Type: Injury
Date Received: February 11, 2013
Date of Event: January 11, 2013
Report Date: January 13, 2013
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HNO
PMA / PMN Number: K060372
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). UPPER LID LACERATION INCLUDING CANALICULUS. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

Description of Event or Problem · 1

SURGEON REPORTED THE LAST PATIENT OF THE DAY WAS QUITE NERVOUS. FIRST FLAP WITH THE IFS 150 WENT FINE AND THE FELLOW EYE WAS DOCKED AND ABOUT TO PROCEED WHEN THE SURGEON HAD SUCTION BREAK CAUSED BY THE PATIENT MOVING HIS HEAD AND HE STARTED TO HAVE WHAT APPEARED TO BE A BRIEF 30 SECOND SEIZURE WHICH WAS PROBABLY MORE A VARIANT OF A VASOVAGAL EPISODE (DESPITE BEING SUPINE). UNFORTUNATELY, HE STARTED CONVULSING/JERKING HIS HEAD AND BODY WHILE IN CLOSE PROXIMITY TO THE CONE. SURGEON DID HIS BEST TO RESTRAIN HIM BUT THIS WAS DIFFICULT AND HE SUSTAINED A REASONABLE UPPER LID LACERATION WITH INVOLVEMENT OF THE CANALICULUS AND SURGEON WAS NOT SURE IF THE MEDIAL CANTHAL TENDON WAS AVULSED. THE CORNEA AND GLOBE ARE INTACT. PATIENT HAS NO HISTORY OF PRIOR VASOVAGAL EPISODES OR SEIZURES ALTHOUGH HE DOES GET NAUSEOUS AND AT TIMES VOMITS WHEN HE GETS A NEEDLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59466	INTRALASE	INTRALASE PATIENT INTERFACE	HNO	ABBOTT MEDICAL OPTICS		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	IFS 150: LOT# UNKNOWN