FDA Adverse Event Injury Summary report: N

VISX WAVESCAN WAVEFRONT SYSTEM

MDR report key: 1241542 · Received November 21, 2008

Report

Report Number: 3006695864-2008-00033
Event Type: Injury
Date Received: November 21, 2008
Date of Event: August 7, 2008
Report Date: October 30, 2008
Manufacturer: ADVANCE MEDICAL OPTICS
Product Code: LZS
PMA / PMN Number: P930016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A FIELD SERVICE ENGINEER (FSE) PERFORMED A EXCIMER AND WAVESCAN EVALUATION AND FOUND THAT BOTH SYSTEMS MET SPECIFICATIONS AND PERFORMED AS INTENDED. CUT PLASTIC WITH THE EXCIMER LASER AND EVALUATED. NO ISSUES WERE DETECTED WITH THE CUT. A CLINICAL DEVELOPMENT SPECIALIST (CDS) PROVIDED SURGERY SUPPORT IN 2008, AND FOUND THE PHYSCIA'S SETTINGS ON THE WAVESCAN WAS SET AT 6MM FOR PUPIL CALCULATION AND NO DAILY CALIBRATIONS WERE PERFORMED SINCE 2008, SINCE THE SWITCH BACK TO THE 3.67 SOFTWARE. A REVIEW OF THE SCANS SHOWED THAT SOME OF THE SCANS WITH SOME LID/LASH OBSTRUCTION WERE NOT IN GOOD FOCUS.

Description of Event or Problem · 1

A PATIENT UNDERWENT BILATERAL LASIK SURGERY IN 2008. POSTOPERATIVELY THE FOLLOWING MONTH, DURING A FOLLOW UP VISIT, IT WAS NOTED THAT THE PATIENT HAD VISUAL ACUITY OF 20/40 IN THE RIGHT (OD) EYE AND 20/70 IN THE LEFT (OS) EYE. PATIENT HAVING TO WEAR GLASSES. THE PATIENT'S PREOPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 OD EYE AND 20/20 OS. PATIENT'S POSTOPERATIVE BCVA IS 20/40 OD AND 20/70 OS AS OF 2008. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE ASSOCIATION BETWEEN THE EVENT AND THE DEVICE IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VISX WAVESCAN WAVEFRONT SYSTEM	WAVEFRONT MEASUREMENT	LZS	ADVANCE MEDICAL OPTICS	0070-1006	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other	STAR EXCIMER