| Brent Hanson - LASIKFRAUD.com 2005-12-22, 6:02 pm |
| Glenn Hagele states that:
"The Alcon LADARVision excimer laser does not appear to have any
inherent design problems and hundreds of thousands of patients have had
satisfactory outcomes. In fact, even those who alledged a problem
acknowledged that no patients were harmed."
However, the FDA has issued a letter describing in detail how the
lasers malfunction as documented at
http://www.lasikflap.com/forum/viewtopic.php?t=3D118
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=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
555 Winderley Pl., Ste. 200
Maitland, FL 32751
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-05-27
April 15, 2005
Mr. Gary A . Woodrell
Vice President
Refractive Manufacturing Operations
Alcon Laboratories, Inc.
2501 Discovery Drive
Orlando, Florida 32826
Dear Mr. Woodrell :
During an inspection of your establishment located in Orlando, Florida
on January 10 - 18, 2005, our Investigator determined that your firm
manufactures the LADARVision 4000 Excimer Laser System. An excimer
laser is a device as defined by Section 201(h) of the Federal Food,
Drug, and Cosmetic Act (the Act), [21 U.S.C. 321(h)].
The above-stated inspection revealed that this device is adulterated
under section 501(h) of the Act, in that the methods used in, or the
facilities or controls used for, the manufacture, packing, storage, or
installation are not in conformance with the Current Good Manufacturing
Practice (CGMP) requirements for medical devices which are set forth in
the Quality System regulation, as specified in Title 21, Code of
Federal Regulations (CFR), Part 820. Significant deviations include,
but are not limited to, the following:
1=2E Failure to review and evaluate all complaints to determine whether
an investigation is necessary. When no investigation is made, the
manufacturer shall maintain a record that includes the reason no
investigation was made and the name of the individual responsible for
the decision not to investigate as required by 21 CFR 820.198(b). (FDA
483, Item #1).
Data downloaded from LADARVision systems currently in use in the U.S.
showed significant differences in the retreatment requirements between
patients treated prior to 15 minutes after calibration of the device as
opposed to patients who were treated after 15 minutes following
calibration of the device. Another table was provided that used the
points of < 30 minutes from calibration to treatment and > 30 minutes
or more from calibration to treatment.
A patient whose surgical procedure is initiated after 30 minutes has a
30% greater risk of retreatment than does the patient whose treatment
commences prior to 30 minutes after calibration. Beam drift occurs if
too much time passes between calibration and treatment, with possible
translation or rotation of the beam.
Your response to this data has been inadequate. There is a note to a
warning to the device user manual, which states, "WARNING: System
calibration must be done between patients and within 15 minutes of
surgery, failure to perform calibration in the time frame indicated may
result in improper orientation of the ablation. " However, there was no
reason provided to explain the use of these times. Moreover, the note
to warning is not by itself sufficient to address the seriousness of
this problem . (FDA 483, Item #1)
2=2E Failure to review, evaluate, and investigate any complaint involving
the possible failure of a device, labeling, or packaging to meet any of
its specifications, unless such investigation has already been
performed for a similar complaint and another investigation is
necessary as required by 21 CFR 820.198(c). Complaints received from
January 1, 2002, through January 10, 2005, revealed the most common
complaint codes as follows:
Class code - 801: Laser not firing,
Class code T 833: Translator malfunction,
Class code - 802A: Loss of tracking, and
Class code - 802B: Not able to track
Complaint records associated with these complaint class codes are not
adequately reviewed, evaluated, and investigated to determine the
root-cause of the system and/or sub-assembly component malfunction (FDA
483, Item #2).
Specific complaints reviewed during the inspection revealed the
following:
a . Complaint Record RS030392 received on April 14, 2003, involving the
LADARVision=AE 4000 Beta, lot number L4B1023S references the laser
stopped firing during surgery at 92% complete. The Field Service
Engineer (FSE) found arcing in the laser chassis assembly. The FSE
adjusted components to prevent future arcing. The complaint record does
not document and confirm that an investigation was conducted to
determine the root cause of the reported problem. The record also fails
to document the justification for not conducting an investigation and
is not signed and dated by responsible personnel.
b=2E Complaint Record RS041106 received on August 23, 2004, involving
LADARVision=AE 4000 Beta, lot number L4B1023S references the laser not
firing. An FSE replaced the laser control electronics that failed. The
replaced component was evaluated and verified the failure was caused by
a broken connector. The record does not document and confirm that an
investigation was conducted to determine the root cause of the broken
connector. The record also fails to document the justification for not
conducting an investigation and is not signed and dated by responsible
personnel.
c=2E Complaint Record RS041047 received on August 11, 2004, involving a
refurbished LADARVision=AE 4000 Beta, lot number L4B1090S referencing
noise from the laser with a system failed error message. A similar
complaint, RS030392 referenced a malfunctioning translator, which was
replaced because of faulty/defective bearings. The complaint was
classified as complaint class 823- Noise Coming from system. The
complaint was more appropriately determined a translator malfunction,
which is complaint class 833. The malfunction causes the laser to stop
operating or firing resulting in surgery being terminated, causing
under correction, which is not considered by your firm to be an injury.
d=2E Complaint Record RS030539 received on May 16, 2003, involving
LADARVision=AE 4000 Beta, lot number L4B1022S referencing loss of
tracking during surgery. Surgery was stopped at 57% complete. The FSE
balanced the infrared pulse and changed the DSP gains. The record does
not document an investigation that was conducted to determine the
root-cause of the report to conduct an investigation into the reported
malfunction.
e=2E Complaint Record RS031262 received on November 14, 2003, involving
LADARVision=AE 4000 Beta, lot number L4B1022S references a laser unable
to track. The FSE confirmed the failure mode and replaced the zoom
motor. The Manufacturing Engineer (ME) confirmed that the motor
performed erratically when operating under a torque and will not
reverse direction when prompted by software. A similar complaint
FS030539 (noted above) does not document that an investigation was
conducted to determine the root cause for the zoom motor failure or the
justification for not conducting an investigation into the malfunction.
3=2E Failure to promptly review, evaluate, and investigate any complaint
that represents an event which must be reported to FDA under 21 CFR
part 803 by a designated individual(s) and shall be maintained in a
separate portion of the complaint files otherwise clearly identified as
required by 21 CFR 820.198(d) and 803..50(b)(2).. (FDA 483, Item #3).
Complaint .Record RS041447 received on November 5, 2004, (MDR
1061857-2004-00011) involving the LADARVision=AE 4000, lot number
L4N1636S referenced the report of a poor clinical outcome. The primary
custom-cornea, lasik procedure conducted on June 4, 2004, resulted in a
two line loss of Best Corrected Visual Acuity (BCVA), 20/20 at pre-op
and 20/30 at the four month post-op visit. A retreatment was conducted
on October 29, 2004, resulting in an additional one line loss of BCVA,
which was 20/30 at four months after post-op and 20/40 at one week
after the retreatment post-op visit. No review, evaluation, and
investigation were conducted of the primary custom-cornea lasik
procedure on June 4, 2004. The retreatment procedure was reviewed,
evaluated, and investigated, which is not covered under the system's
labeling including the collection of data such as Operative Summary,
LadarWave printouts, and Operative Reports. The complaint was closed
December 13, 2004. No review, evaluation or investigation was conducted
of the primary custom-cornea, lasik procedure which occurred on June 4,
2004.
4=2E Failure to establish and maintain procedures that define the
responsibility for review and the authority for the disposition of
nonconforming product as required by 21 CFR 820.90(b)(1). (FDA 483,
Item #4). Your own procedures, specifically, SOP 7501-00.38, Field
Returns, and SOP 7003-0909, Evaluation of Non-Conforming Parts Returned
from Field Service, are not followed:
a=2E Complaint Record RS040448 - Per the referenced SOPs all parts
replaced in the field are to be returned for evaluation. An evaluation
of malfunctioning translators was not conducted as required and the
service activity was considered routine maintenance instead of being
assessed as a complaint.
b=2E Complaint Record RS040031 - Per the referenced SOPs gas filters were
not returned for evaluation and an evaluation was not performed. This
report was evaluated by Product Safety (PS) and classified as a
"Malfunction". Personnel experienced headache, dry tight throat, and
nausea resulting in an emergency room (ER) visit.
c=2E Complaint Record RS031155 - A FSE found a lead washer was unevenly
crimped, which he replaced. The part was not returned and an evaluation
was not performed. A MDR was evaluated by your PS team and classified
as "Other" without explanation. Personnel experienced vomiting and
nausea resulting in an ER visit.
The above-stated inspection also revealed that your device is
misbranded under section 502(t)(2) of the Act, in that your firm failed
or refused to furnish any material or information required by or under
section 519 respecting the device. Specifically, your firm failed to
report within 30 days whenever the manufacturer receives or otherwise
becomes aware of information, from any sources, that reasonably
suggests that a device marketed by the manufacturer has caused or
contributed to a death or serious injury, as required by 21 CFR
803.50(a)(1).
The following complaints referencing serious injuries where not
submitted within 30 days to FDA as required:
a=2E Complaint Record RS041329
b=2E Complaint Record RS030632
Your firm also failed to investigate adverse event reports and to
evaluate the cause of the reported event as required by 21 CFR
803.50(b)(2). The following adverse event reports have not been
adequately investigated as required:
a=2E Complaint Record RS030392
b=2E Complaint Record RS041106
c=2E Complaint Record RS041047
d=2E Complaint Record RS031262
e=2E Complaint Record RS030355
f=2E. Complaint Record RS031146
g=2E Complaint Record RS030632
h=2E Complaint Record RS031257
This letter is not intended to be an all-inclusive list of violations
at your facility. It is your responsibility to ensure compliance with
applicable laws and regulations administered by FDA. The specific
violations noted in this letter and in the Inspectional Observations,
Form FDA 483 (FDA 483), issued at the closeout of the inspection may be
symptomatic of serious problems in your firm's manufacturing and
quality assurance systems. You should investigate and determine the
causes of the violations, and take prompt actions to correct the
violations and to bring your products into compliance.
We have reviewed your response, dated February 3, 2005. We acknowledge
that you have proposed to improve your complaint handling procedure. We
would appreciate receiving the periodic reports that you have promised.
Nevertheless, your response to the violations discussed above is
inadequate because our review of the data shows that reviews,
evaluations, and corrective actions were not fully assessed. Also your
own procedures were not followed and misinterpretations were made as to
the status of complaints that were reported and the conclusions that
were drawn, which affected the corrective actions that were required.
You should address each and every observation when responding to this
letter. Your response has been made part of the Florida District file.
Additionally, no premarket submissions for Class III devices to which
QS regulation deficiencies are reasonably related will be cleared until
the violations have been corrected. Also, no requests for Certificates
to Foreign Governments will be approved until the violations related to
the subject devices have been corrected. You should take prompt action
to correct these deviations. Failure to promptly correct these
deviations may result in regulatory action being initiated by the Food
and Drug Administration without further notice. These actions include,
but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within fifteen (15) working days
of receipt of this letter, of any steps that you are still in the
process of taking to correct the noted violations, including (1) the
time frames within which the corrections will be completed, (2) any
documentation indicating the corrections have been achieved, and (3) an
explanation of each step being taken to identify and make corrections
to any underlying systems problems necessary to assure that similar
violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer,
Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland,
Florida 32751, (407) 475-4728.
Sincerely,=20
/S/=20
Emma R . Singleton=20
Director, Florida District
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