FDA Adverse Event Injury Summary report: N

LENSX LASER SYSTEM

MDR report key: 2881562 · Received December 17, 2012

Report

Report Number: 3008772169-2012-00050
Event Type: Injury
Date Received: December 17, 2012
Date of Event: November 20, 2012
Report Date: November 20, 2012
Manufacturer: ALCON - LENSX LASERS, INC.
Product Code: OOE
PMA / PMN Number: K101626
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LASER, AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. THERE WAS NO SAMPLE RETURNED FOR EVAL, AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. BASED ON AVAILABLE INFO, THE LIKELY CAUSE OF THE REPORTED ISSUE WAS DUE TO THE DOCTOR'S TECHNIQUE AND LEARNING CURVE. CAPSULAR TEARS ARE AN INHERENT RISK OF CATARACT SURGERY. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED THAT WHILE PERFORMING LASER CAPSULORHEXIS, THERE WERE A FEW MINOR CAPSULAR TAGS. THE ANTERIOR CHAMBER INCREASED, BUT THERE WERE NO VISIBLE SIGNS OF A TEAR. ALSO, THERE WERE NO SIGNS OF VITREOUS PRESENTATION, HOWEVER, VISUALIZATION WAS HAMPERED BY POSTERIOR BUBBLES. IT WAS DECIDED NOT TO INSERT THE IOL (INTRAOCULAR LENS) AT THIS TIME, AND THERE IS THE POSSIBILITY THAT A VITRECTOMY MAY BE NEEDED IN THE FUTURE. THE SURGEON REPORTED THAT HE FELT THE LASER DID NOT CAUSE ANY PROBLEM; HIS TECHNIQUE AND LEARNING CURVE ARE POTENTIAL FACTORS. THE IOL IMPLANT HAS NOT YET BEEN SCHEDULED. ADDITIONAL INFO HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LENSX LASER SYSTEM	OPHTHALMIC FEMTOSECOND LASER	OOE	ALCON - LENSX LASERS, INC.	550	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention