Surgilight, Inc. Warning Letter

From: Subject: Surgilight, Inc. Warning Letter Date: Mon, 3 Mar 2008 11:14:36 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_00AF_01C87D1F.C3F09040" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_00AF_01C87D1F.C3F09040 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/archive/g4689d.htm Surgilight, Inc. Warning Letter

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Department of Health and Human = Services	Public Health Service Food and Drug = Administration
	555 Winderley Pl., Ste 200 Maitland, FL 32751=20

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-04-29

April 20, 2004

Timothy J. Shea, President
Surgilight, Inc.
12001 Science=20 Drive
Suite 140
Orlando, Florida 32826-2916

Dear Mr. Shea:

During an inspection of your establishment located in Orlando, = Florida on=20 January 12-26, 2004, FDA Investigators R. Kevin Vogel, Leo Lagrotte, and = Electra=20 Optics Specialist, Max Lager determined that your establishment is a=20 manufacturer of the Optivision Laser System intended for laser = presbyopia=20 reversal (LAPR), which is defined as a medical device under section = 201(h) of=20 the Federal Food, Drug, and Cosmetic Act (the Act).

The investigator documented significant violations from the Quality = System=20 (QS) Regulations, Title 21, Code of Federal Regulations (CFR), Part 820. = These=20 violations cause the device you manufacture to be adulterated within the = meaning=20 of Section 501 (h) [21 U.S.C. =A7351 (h)] of the Act.

The investigator noted the following violations of the QS = regulations:

1. Your firm's management with executive responsibility failed to = review the=20 suitability and effectiveness of the quality system at defined intervals = and=20 with sufficient frequency according to established procedures to ensure = the=20 quality system satisfies the requirements of this part and the = established=20 quality policy and objectives as required by 21 CFR 820.20(c). Your firm = failed=20 to correct numerous deficiencies of the Quality System Requirements that = were=20 observed during previous FDA inspections dated April 2002 and 2003 and = the=20 current inspection: including FDA 483, Item #s 2, 3b, 5, 6, 8 & 9. = During=20 the current inspection, complaints concerning energy malfunctions of the = Optivision Laser System and in-house failures of the handpiece fiber = assemblies=20 or tips were not adequately reviewed, evaluated and documented during = quality=20 review meetings when the firm's president was present (FDA 483, Item = #7).

2. Your firm's internal quality audits failed to verify that the = quality=20 system is effective in fulfilling quality system objectives as required = by 21=20 CFR 820.22. Your firm's internal audits failed to address numerous = deficiencies=20 of the Quality System Requirements observed during the present FDA = inspection=20 and previous FDA inspections. Your firm failed to include audit criteria = covering validation/qualification and Medical Device Reporting (MDR)=20 requirements. This observation was observed during the April 2003 = inspection and=20 was not corrected (FDA 483, Item #8).

3. Your firm failed to validate and approve processes whose results = cannot be=20 fully verified by subsequent inspection and test according to = established=20 procedures as required by 21 CFR 820.75(a). Your firm failed to validate = the=20 following operations

a) Complete validation of cleaning instructions included in the = Optivision=20 Service and Operational Manual for laser tips.
b) Validation study to = assure=20 that polished tips obtained from Premier Laser Systems will retain 90% = of=20 initial transmission efficiency when exposed to recommended steam = sterilization=20 cycles is inadequate because (i) only five contact tips were assessed = during the=20 sterilization testing and no statistical rationale was provided that = this was a=20 valid sample. Further, these five contact tips exhibited degradation of = coating=20 but reportedly did not cause failure to reach 90% transmission goal = (This=20 observation was repeated from the April 2003, FDA 483); (ii) = Sterilization=20 validation failed to include 50 resterilizations of contact laser fiber = tips=20 even though management states that the tips could be used up to 50 = times; (iii)=20 there is no specification for water quality for steam sterilization = cycles=20 recommended for laser fiber tips to assure debris (minerals, etc.) does = not=20 compromise quality of tips.
c) Validation of Borland Compiler is = incomplete=20 because software used to control passwords was not addressed (FDA 483, = Item=20 #3).

4. Your firm failed to analyze all data from quality sources to = identify=20 existing and potential causes of nonconforming product and other quality = problems as required by 21 CFR 820.100(a)(1). Trend analysis was not = conducted=20 of in-process rejects as non-conformances and fiber failures are not = documented=20 in the quarterly trend report of nonconformances. One fiber was observed = hanging=20 in the testing room during this inspection and was labeled as a burned = fiber.=20 Surgilight personnel stated the component failed during in-house testing = (FDA=20 483, Item #12).

5. Your firm failed to implement corrective and preventive action = procedures=20 for investigating the cause of nonconformities relating to product, = processes,=20 and the quality system as required by 21 CFR 820.100(a)(2).

Your firm failed to follow SOP (RMA procedure, Section 5.14 dated = March 14,=20 2003) requiring that there be specific findings documented concerning = failed=20 fibers, not just a description of broken, burnt or damaged. This = observation was=20 made during the April 2002 and 2003 inspection (FDA 483, Item #13).

6. Your firm failed to take appropriate action to correct and prevent = the=20 recurrence of identified nonconforming product and other quality = problems as=20 required by 21 CFR 820.100(a)(3). Your firm received a minimum of 34 = reports of=20 low or high energy, broken fibers, or burned fibers for the Optivision = Laser=20 fiber delivery systems from the field and no evaluation or investigation = was=20 performed and/or documented (FDA 483, Item #1).

7. Your firm failed to review, evaluate, and investigate all = complaints=20 involving the possible failure of a device to meet any of its = specifications as=20 required by 21 CFR 820.198(c). The following are examples of Return = Material=20 Authorizations (RMA), Field Service Reports, and complaints that were = not=20 adequately investigated:

a) RMA #110601-03A dated December 15, 2003, reports that one fiber = and one=20 tip were burned in Greece. No investigation was conducted.
b) Field = Service=20 Report dated March 26, 2002 references energy settled down after move to = air=20 conditioned room, that two fibers broke at the handpiece, that during = set up the=20 next day, the SMA funnel came out with the fiber, and the system went = into fault=20 #14, water flow. Report was not treated as a complaint. Complaint #s 96 = dated=20 March 13, 2003, and 107 dated June 13 & 17, 2003, both of which = reported no=20 or low energy output at the fiber tip and no investigation was = documented.
c)=20 Complaint #4 dated October 15, 2001, references fiber was = defective.
d)=20 Complaint #5 dated September 20, 2001, references laser system failed to = power=20 up. Firm repaired high voltage cable connect (J3-J15), the red wire = which was=20 found to be broken. There was no determination as to what caused the=20 failure.
e) Complaint #s 9 and 10 dated October 15, 2001, reference a = reconfiguration of the footswitch for two systems but do not identify = why or=20 what reconfiguration was done.
f) Complaint #17 dated December 17, = 2001,=20 references software locked up due to possible computer time and/or = patient file=20 recreation. Failure not determined.
g) Complaint #21 dated January = 18, 2002,=20 references that fiber did not fit flush with the handpiece and caused = breakage=20 of fiber at tip. No investigation completed.
h) Complaint #38 dated = May 31,=20 2002, references that fiber broke and no investigation completed.
i)=20 Complaint #100 dated April 24, 2003, references System Fault #16, = temperature.=20 No investigation documented. j) Complaint #s 106 dated June 3, 2003, and = 72=20 dated November 27, 2002, reference aiming beam shutter stuck closed on = power up.=20 No investigation documented.
k) Complaint #109 dated June 17, 2003 = references=20 high energy and no investigation was conducted. (FDA 483, Item #9).

8. Your firm failed to establish and maintain complete procedures to = ensure=20 that all purchased or otherwise received product and services to conform = to=20 specified requirements as required by 21 CFR 820.50. All components to=20 manufacture laser systems including handpiece assemblies and tips were = received=20 from Premier Laser Systems. The firm only studied three laser systems to = verify=20 that pulse-to-pulse stability met specifications (+/-10%). The three = systems=20 fail to be statistically relevant to verify that Premier is a reliable = supplier.=20 Your firm also failed to include fibers and tips in the study and there = is no=20 written protocol describing the study (FDA 483, Item #10).

9. Your firm failed to implement procedures to verify that design = outputs=20 meet design inputs as required by 21 CFR 820.30(f). Your firm failed to = verify=20 that the fiber delivery system could withstand multiple uses. The firm = received=20 34 reports of events involving low and high energy, broker fibers and = burned=20 fibers. Fibers with hairline cracks can result in power fluctuations and = may=20 affect surgical procedures. Your firm's design plan refers to several = items=20 previously completed by Premier, but most of these items have never been = verified (FDA 483, Item #2). This observation was previously listed on a = FDA 483=20 during both the April 2002 and 2003 inspections and no corrective action = was=20 taken.

10. Your firm's design validation failed to ensure that modified = software=20 designed for use with the Scan 195 was appropriate for use with the = Optivision=20 Laser System as required by 21 CFR 820.30(g). The software controls the = password=20 to allow use of the device when programmed for a specific period of = time. A=20 portion of the source code also included questions that were not = answered by=20 validation or verification (FDA 483, Item #4).

11 .Your firm failed to conduct design validation and risk analysis = as=20 required by 21 CFR 820.30(g). Failure of the sapphire fiber during = surgery was=20 not included in any risk analysis conducted. There also was a failure to = include=20 steam sterilization of the tips and sterile drapes as part of the risk = analysis=20 procedures. This item was observed during the April 2002 inspection and = was not=20 corrected (FDA 483, Item #5).

12. Your firm failed to include a mechanism to address incomplete, = ambiguous,=20 or conflicting requirements as required by 21 CFR 820.30(c). The design = input=20 requirements for the fiber delivery system are incomplete except for = statements,=20 such as "Transmission > +50%," "Handpiece for easy handling," " = Removable=20 from laser," "Fiber status monitoring," and "non-conducting material." = This=20 observation was made during the April 2002 and 2003 inspections and was = not=20 corrected (FDA 483, Item #6).

13.Your firm failed to identify, document, validate/verify, review, = and=20 approve design changes prior to implementation as required by 21 CFR = 820.30(i).=20 Reconfiguration of the footswitch made, as a result of Complaint #s 9 = & 10=20 dated October 15, 2001, was implemented without the design change being=20 documented, verified and approved prior to implementation (FDA 483, Item = #11).

This letter is not intended to be an all-inclusive list of = deficiencies at=20 your facility. It is your responsibility to ensure adherence to each = requirement=20 of the Act and regulations. Federal agencies are advised of the issuance = of all=20 Warning Letters about devices so that they may take this information = into=20 account when considering the award of contracts.

You should take prompt action to correct these deviations. Failure to = promptly correct these deviations may result in regulatory action being=20 initiated by the Food and Drug Administration without further notice. = These=20 actions include, but are not limited to, seizure, injunction, and/or = civil=20 penalties. Additionally, no premarket submissions for Class III devices = to which=20 QS regulation deficiencies are reasonably related will be cleared until = the=20 violations have been corrected.

Also, no requests for Certificates for Products for Export will be = approved=20 until the violations related to the subject devices have been corrected. = Please=20 notify this office in writing within fifteen (15) working days of = receipt of=20 this letter, of the steps you have taken to correct the noted = violations,=20 including (1) the time frames within which the corrections will be = completed,=20 (2) any documentation indicating the corrections have been achieved, and = (3) an=20 explanation of each step being taken to identify and make corrections to = any=20 underlying systems problems necessary to assure that similar violations = will not=20 recur.

Your response should be sent to Timothy J. Couzins, Compliance = Officer, Food=20 and Drug Administration, 555 Winderley Place, Suite 200, Maitland, = Florida=20 32751, (407) 475-4728.

Sincerely,
/s/
Emma Singleton
Director, Florida = District

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FDA/Freedom=20 of Information

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