FDA Adverse Event Malfunction Summary report: N

INTRALASE

MDR report key: 5552133 · Received April 6, 2016

Report

Report Number: 2648035-2016-00525
Event Type: Malfunction
Date Received: April 6, 2016
Report Date: April 6, 2016
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HNO
PMA / PMN Number: K060372
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SG
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UDI #: NOT AVAILABLE SINCE PRODUCT LOT NUMBER IS UNKNOWN EVENT DATE - UNKNOWN. EXPIRATION DATE - UNKNOWN SINCE PRODUCT LOT NUMBER IS UNKNOWN. THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR¿S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR¿S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT¿S CORNEA AND THE SUCTION RING. DEVICE MANUFACTURE DATE - UNKNOWN SINCE PRODUCT LOT NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PUBLICATION: MARCUS A, MEHTA J.S., ROSMAN M, LI L, KOH JCW, HTOON HM. TAN D, CHAN C. VISUAL OUTCOMES COMPARISON OF 2 FEMTOSECOND LASER PLATFORMS FOR LASER IN SITU KERATOMILEUSIS. J CATARACT REFRACT SURG 2013; 39:1647¿1652.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING PROCEDURE AND WHILE LASER WAS FIRING THE PATIENT INTERFACE EXPERIENCED A SUCTION LOSS. IT WAS REPORTED THAT THE DOCKING CONE WAS REAPPLIED AND THE FEMTOSECOND LASER PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED GOOD VISUAL RESULTS 3 MONTHS POSTOPERATIVELY, WITH A FINAL CORRECTED DISTANCE VISUAL ACUITY OF 20/20.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
208762	INTRALASE	PATIENT INTERFACE	HNO	ABBOTT MEDICAL OPTICS	PI-RET

Patients

Seq	Age	Sex	Outcome	Treatment
1