PHOENIX OPHTHALMOLOGISTS EYE CARE AND LASER CENTER  
     
     


LADARVISION LASER



Alcon Replaces Malfunctioning Part in 136 LADARVision Excimer Lasers
Alcon has replaced a malfunctioning device responsible for regulating the laser pulse in 136 LADARVision excimer laser systems nationwide in the U.S. and in other countries, said a company spokesperson. The device, called a thirotron, was found to shoot unanticipated laser pulses that can create central corneal defects of about 1mm in diameter in LASIK patients. Alcon installed the redesigned thirotrons in 136 systems in January, said the spokesperson.


FDA Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


May 16, 2001 01-19



PRODUCT:
LADARVision Excimer System and LADARVision 4000 Excimer Laser System
a) Product No. 6509-0078; Z-537-1.
b) Product No. 6509-4000; Z-538-1.
c) Product No. 6509-0285; Z-539-1.
d) Product No. 6509-0126; Z-540-1.
e) Product No. 6509-0131; Z-541-1.
f) Product No. 6509-0137; Z-542-1.
g) Product No. 6509-0336; Z-543-1.
CODE:
10, 12, 14, 17, 1018, 1019, 21, 22, 23, 1025, 26, 1027, 28,
30 to 34, 1035 to 1037, 38 to 42, 44 to 49, 1051 to 1060,
1062 to 1064, 1066, 1068 to 1079, 1081, 1085 to 1111, 1113
to 1129, 1131 to 1134, 1136 to 1144, 1147 to 1150, 1152,
1154, 1156 to 1158, 1160, 1163, 1168, 1169, 1190, 1192 to
1195, 1199, and 1200.
MANUFACTURER:
Autonomous Technologies Corp., Orlando, FL
RECALLED BY:
Manufacturer, by letter and facsimile onJanuary 20 and 24, 2001.
DISTRIBUTION:
Nationwide, and Canada, Italy, United Kingdom, Spain, Australia, Greece,
Thailand, Phillipines.
QUANTITY:
136 units.
REASON:
Devices adulterated in that unanticipated laser pulses reaching the
cornea will cause ablation of the corneal surface, which could result in
a central corneal defect of about 1mm in diameter.

END OF ENFORCEMENT REPORT FOR May 16, 2001.

A SECOND RECALL

OCULAR SURGERY NEWS 9/15/03
Alcon recalls LADARWave software
Michelle Dalton Liberatore


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Alcon has initiated a recall of the software in 157 LADARWave CustomCornea units because of a software error that may lead to ophthalmologists? retrieving patient data incorrectly, according to the Food and Drug Administration.

The FDA noted the recall was company-initiated and affects the aberrometer software version 7.91 in Alcon?s LADARVision System. According to the FDA information, the software error ?could, under specific circumstances, allow the patient?s centration images and data to be stored incorrectly.?

According to an Alcon spokeswoman, the company sent out a safety alert to all LADARWave owners last month. ?We didn?t ask anything to be returned,? Mary Dulle, corporate communications director, told Ocular Surgery News. The software glitch, she said, is in the ?sort by? function.

?We?re asking users not to sort patient data by ?sort by first name? or ?sort by last name?,? she said. Searching by patient name or medical record is unaffected by the glitch, she added.

Ms. Dulle added that of the 109 domestic units affected, every ophthalmologist is in receipt of the letter and has sent back information saying they?ve read the safety alert and taken appropriate precautions. Internationally, 42 of 48 sites have responded affirmatively, Ms. Dulle noted. ?We are making every effort to contact the remaining sites to alert them as well,? she said.

Alcon is debating whether to reprogram the ?sort by? feature or eliminate it completely on future versions of its software.

Daniel S. Durrie, MD, told Ocular Surgery News, ?there are several other checks in the actual procedure that would avoid actually treating the wrong eye. I am unaware of any patient problem, and it has not affected patient treatment here at all.?


OPHTHALMOLOGY MANAGEMENT APRIL 2007

Ladar6000 problem. On Feb.21.2007, Alcon Refractive Horizons, inc. issued a safety
Alert to the 99 refractive surgeons using its LADAR6000 exciter laser. The alert directed physicians to discontinue performing Custom Cornea myopia procedures due to reports from seven surgical centers citing topographically observed "central islands," Alcon's preliminary analysis led the company to file a Pre-Market Approval (PMA) supplement with the PDA, proposing that the issue could be resolved by reversing the direction of the ablation pattern and resetting the repetition rate to 60 Hz. This PMA supplement is currently under review by the PDA.
Alcon distributed a follow-up communication to LADAR6000 users in mid-March to reiterate the direction provided in the February 21 letter and to gain additional information that would help the PDA evaluate the company's proposed plan of action. Alcon says it will notify its customers when the specific course of action to correct the "central island" issue is approved and can be implemented