STAR S4-IR-ETL EXCIMER LASER

MDR report key: 3482510 · Received November 21, 2013

Report

Report Number: 3006695864-2013-00410
Event Type: Injury
Date Received: November 21, 2013
Date of Event: October 25, 2013
Report Date: October 25, 2013
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: LZS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA/510(K) P930016. DEVICE MANUFACTURE DATE 3/9/2006. PLACEHOLDER.

Additional Manufacturer Narrative · 1

THE AMO FIELD SERVICE ENGINEER REPORTED THAT DURING INSTALLATION OF INTRALASE, THE PATIENT CHAIR UP/ DOWN MOVEMENT WAS ENABLED IN ORDER TO ADJUST THE CHAIR TO THE HEIGHT AS PER THE CUSTOMER REQUEST. BY OVERSIGHT, THE ENGINEER FAILED TO DISABLE THE CHAIR MOVEMENT AFTER CORRECTING THE CHAIR HEIGHT. THE FIELD SERVICE ENGINEER WAS ALLOWED TO RETURN TO DISABLE THE CHAIR SWITCH FOLLOWING THE INCIDENT, HOWEVER THE CUSTOMER HAS NOT ALLOWED A FULL SYSTEM EVALUATION. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

Description of Event or Problem · 1

THE DOCTOR REPORTED THAT WHILE PREPARING TO PERFORM A CORNEAL FLAP CUT FOR A LASER VISION CORRECTION PROCEDURE THE PATIENT CHAIR WITH THE PATIENT SITUATED IN THE CHAIR MOVED ON ITS OWN IN AN UPWARDS MOTION. THE PATIENT'S FOREHEAD CAME IN CONTACT WITH THE SYSTEM ILLUMINATION RING AND RECEIVED SEVERAL LACERATIONS. THE WOUND WAS CLEANED AND REQUIRED SUTURING. THE PATIENT WAS TREATED WITH ANTIBIOTICS, PAIN RELIEVERS AND TETANUS VACCINATION. THE PATIENT WAS REQUESTED TO FOLLOW-UP ON A REGULAR BASIS. THE PATIENT UNDERWENT A CT SCAN WHICH REVEALED A FRACTURE. THE SEVERITY IS UNKNOWN AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
604823	STAR S4-IR-ETL EXCIMER LASER	EXCIMER LASER	LZS	ABBOTT MEDICAL OPTICS	STAR S4-IR-ETL

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR		Hospitalization