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DEPARTMENT OF HEALTH AND HUMAl"I SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

10903 New Hampshire Avenue 1/30/2017 - 2/2/2017 Silver Spring, 20993 FEI NUMBER

(301)594-4695 Fax : (301)594-4715 3004135191

NAME ANO TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Tzipi (NMI) Ozer-Armon ' CEO FIRM NAME STREET ADDRESS

Lumenis Limited 6 Hakidma St . ,Yokneam Ind . Park CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Yokneam, 20692Israel Medical Device Manufacturer

TI1is document lists observations made by the FDA representative{ s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency detenuination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, co!l'ective action in response to an observation, you may discuss the objection or action with the FDA representative{s) during the inspection or submit this info=tion to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.

The observations noted in this Form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self audits to identify and co,,rect any and all violations of the quality system requirements.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1 An MDR repo1i was not submitted within 30 days of receiving or othe1w ise becoming aware of infonnation that reasonably suggests that a marketed device may have caused or contributed to a death or sen ous mJmy.

Specifica lly, MDRs associated with product complaints we re not a lways reported within 30 days. Examples include:

• Complaints~t>) (4) I through i6J (4 ) I fo r patient burns caused by a LightSheer Desire

device with fi rm awareness date of 11/ 07/2014. The associated MOR 1720381-2015-00006 was not

reported until 01/30/ 2015.

• Complaint~6f{4) I for patient third degree burns and scarring caused by the LightSheer Duet with

a firm awareness date of 10/ 09/2015. The associated MOR 3004135191-2016-00004 was not reported

unti l 03/02/2016.

• Complaint[(t>) (4) I for first and second degree burns caused by a LightSheer Duet device with a

firm awareness date of 12/28/2015. The associated MOR 3004135191-2016-00063 was not reported

unti l 02/28/2016.

• Complaint[(t>) (4) I for patient burns caused by a LightSheer Duet resulting in permanent scaring

with firm awareness date 04/26/2016. The associated MOR 3004135191-2016-00016 was not reported

unti l 11/ 16/2016.

AMENDMENT 3

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Cynthia L Gorveatt, Investigator 'l/15/2017 2/15/2017 OF THIS PAGE Donna L Besone, Investigator X Cynthra LG«.-

Cyntt,IILGtltYutt ~-"" S9"e:I bt': c:-,.h• L Gtrvutt -$

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE I OF9 PAGES



10903 New Hampshir e Avenu e 1/30/2017 - 2/2/2017 Silver Spring , 20993 FEI NUMBER

(301)594 - 4 695 Fax : (301)594 - 4 715 3004 135191


Tz i p i (NMI) Oze r - Armon ' CEO FIRM NAME STREET ADDRESS

Lumenis Li mited 6 Hakidma St ., Yokneam Ind. Park CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Yokneam, 20692Israel Me d ica l Device Manufacture r

• Complaint[(I:>) (4) I for thermal injury during tonsillectomy with CO2 laser device with a fi rm

awareness date of 06/ 15/ 2016. The associated MOR 3004135191-2016-00040 was not reported until

11/ 17/ 2016.

• Complaint4 1:>)l4) I H1Fe~gh ~Df(21) !-for patient burns caused by use of a M22 IPL laser

with a fi rm awareness date of 09/ 30/ 2016. The associated MOR 3004135191-2016-000044 was not

reported until 12/ 15/ 2016.

• Complaint~6) (4) I for patient extended surgery (2+ hours), stitches, and open wound, cause by a

malfunction of VersaCut + (plus) with a firm awareness date of 10/ 28/ 2016. The associated MOR

3004135191201700010 was not reported until 01/ 26/ 2017.

You r firm opened CAPAl(b) (4)J on 01/ 12/ 2017 to address the issue of not reporting MDRs w ithin 30 days, after

the current inspection had been pre-announced.

Additionally, your fi rm's Complaint Handling Unit Manager identified that the following complaints should have

been reported as MDRs; however, as of the start of the inspection an MOR had not been reported:

• Complaint~6f{4) I for patient sustaining hair loss in the jaw line following acne t reatment caused

by use of M22 Acne Filter w ith a firm awareness date of 01/ 10/ 2015. This malfunction/ adverse event

was never reported. The firm initiated a recall of M22 Acne fi lters on 11/ 17/ 2015. The FDA became

aware of the recall on 04/ 06/ 2016 (Z-1669-2016).

• Complaint~6) (4) I for user sustaining burn to finger caused by product malfunction with a firm

awareness date of 02/ 09/ 2016. You r firm's CHU Manager confirmed that this is a malfunction that

could resu lt in serious inju ry if it were to recur.

OBSERVATION 2 Written MDR procedures have not been implemented.

Specifically, your firm's MOR procedure, Global Medica l Device Reportind 6>l 4)~ requires a list of

malfunctions to be maintained; how ever, your firm's management acknow ledged that the list did not exist.

AMENDMENT 3


SEE REVERSE Cynth i a L Gor vea tt , Investiga tor 'l/15/2017 2/15/2017 OF THIS PAGE Donna L Besone , Investiga tor X Cynthra LG«.-


FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE2 0 F9 PAGES


DISTRICT ADDRESS ANO PHONE NUMBER

10903 New Hampshir e Avenu e Silver Spring , 20993 (301)594 - 4 695 Fax : (301)594 - 4 715


Tz i p i (NMI) Oze r - Armon , CEO FIRM NAME

OATE(S) OF INSPECTION

1/30/2017 - 2/2/2017 FEI NUMBER

3004 135191

STREET ADDRESS

Lumenis Li mited 6 Hakidma St ., Yokneam Ind. Park CITY. STATE.ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED


OBSERVATION 3 Procedmes for conective and preventive action have not been adequately established.

Specifi ca lly, a) Appropriate statistical methodology was not employed for complaint trending data to detect recurring quality

problems as demonstrated by the following:

• Your firm 's procedure Global CAPA Process, Doc. No. (6)1.i:J effective 5/ 12/ 12 documents --------CAP As could be initiated as a result of negative trends in complaints and requires CAPAs to be

considered when trend threshold values have been exceeded. Complaint trending data for 2015 and

2014 does not indicate the CAPA thresholds for the data and your firm could not provide justification for

not using normalized data .

• Your firm 's procedures{6)l.i:J} CAPA Procedure, Doc. No. {6) (4) , effective

1/4/ 16-1/ 19/ 17, document complaints and trending data as inputs into the CAPA system. Complaint

trending data for 2016 documents the threshold for opening a CAPA to be. l6)7 in a list of all deviefr manufactured by the

firm, result ing in a threshold of(6) (4 )for complaint quantity and (6) (4) for complaint rate. However,

there is no justification for the threshold being 6) (4) -------b) Your firm 's procedure (6)1.i:J CAPA Procedure, Doc. No. 6) 21) , effective 1/ 4/ 16-

1/ 19/ 17, requires the determination of the root cause of nonconformances. Your firm opened CAPA 6J (.i:J) on

2/ 3/ 16 to document the corrective actions taken for the M22 Acne Filters in response to a recall. A firm

employee verbally explained a contributing factor was the (6)14

SEE REVERSE OF THIS PAGE

FORM FDA 483 (09/08)

. Your firm did not have justification for the

Your firm did not identify this as a contributing root cause in the

AMENDMENT 3

EMPLOYEE(S) SIGNATURE

Cynthia L Gor vea tt , Investiga tor Donna L Besone , Investiga tor

PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS

DATE ISSUED

'l/15/2017 2/15/2017

PAGE3 0 F9 PAGES




(301)594 - 4 695 Fax : (301)594 - 4 715 3004 135191





CAPA, and did not implement corrective actions to prevent the issue from recurring. Testing performed on the

~6f{4J1 acne fi lter resulting from the CAPA did not provide justification fo r the sampling plan ~l>Hil)] acne

fi lters) and did not identify the batch from which the acne fi lters were selected. CAPA~t>f (4~ was closed

1/ 16/ 17.

OBSERVATION 4 The results of design validation, including method(s), the date and the individual(s) perfonning validation, were not adequately documented in the design histo1y file.

Specifica lly, your firm fa iled to provided adequate records to demonstrate that the VersaCut+(plus) design validation (System Test Plan for VersaCut+J 6) (4)1 effective date 06/ 03/ 2012 and VersaCut+ V&V Summary report ,r6J (4)7, effective date 09/ 17/ 2013): was conducted under defined operating conditions on init ial production units, lots or batches, or their equiva lents; demonstrated that the device conformed to defined user needs and intended uses; and was conducted on production units under actual or s imulated use condit ions.

In addit ion, the results of design validation, including the date and the individua l(s) perfo rming va lidation, were

not adequately documented in the design history fi le.

OBSERVATION 5 Procedmes for design input have not been adequately established.

Specifica lly, a) The ~6) (4) I System Technica l Specifications, Doc. No.~6) (4) I, effective 12/ 27 / 16, does not

include tole rances fo r acne fi lter wave lengths or fluences. Wave length tolerances documented on

manufacturing work instructions (Doc. No. io) (4) I) are diffe rent than tolerances on device drawings

(Drawing No. ~6>141 I) . Fluence tolerances were documented on verification testing Doc. No. ~6f(4}7,

effective 11/ 27 / 14~D) (4) I and Doc. No.~6) (4)7, effective 12/ 28/ 15~6J (4)7 . Addit ionally, as part of CAPA

~ , your firm identified lack of cl ear tolerance criteria for the~b) {4) I as a contributing factor. As

AM ENDMENT 3







10903 New Hampshir e Avenu e Silver Spring , 20993 (301)594 - 4 695 Fax : (301)594 - 4 715


Tz i p i (NMI) Oze r - Armon , CEO FIRM NAME


1/30/2017 - 2/2/2017 FEI NUMBER

3004 135191

STREET ADDRESS

Lumenis Li mited 6 Hakidma St ., Yokneam Ind. Park CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED


a corrective action, your firm (6)14 (Drawing No. 6)121) ) for the acne fi lter to (t>frt _______ _. ._ ____ ... . However, these changes we re not documented in the design inputs.

b) For CAPA (6) (4) your firm identified unclear design input requirements for the (6) (4) as a

root cause. Changes to the (b) {4) specifications were made and verification testing was

performed in (b) (4) 2015. However, you r firm does not have documentation of the signatures

associated with the input review and approval, and the input specifications were not added to a controlled input

document until 1/ 20/ 16.

OBSERVATION 6 Procedmes for design verification have not been adequately established.

Specifica lly, a) You r firm released the (b) (4)

included 6) (4 )

as a correction for a recall (Z-1519-2015); the change

. The ve rification testing{6J (41 ---- -----------, effective 1/ 15/ 15, does not document the date the testing was

performed and your fi rm could not provide the raw data from the t ime of testing to support the "pass"

determinations.

b) Your firm released (b) (4) as a correction for a recall (Z-1669-2016); the change included 6) (4) . The verification testing for 6) (4) , System Test ---Report for (b) (4) , effective 12/ 28/ 15 and System Test Report fo r(b) (4) --------, effective 12/ 28/ 15 do not document the date testing was performed or identify the batch from

""w_h_i-ch- fi-lt-e-rs- w- e re selected. Additionally, the 6) (4 ) specification was not tested as part of design ve rification.

OBSERVATION 7 Design plans were not reviewed, updated and approved as design and development evolves.


FORM FDA 483 (09/08)

AM ENDMENT 3


Cynth i a L Gor vea tt , Investiga tor Donna L Besone , Investiga tor


DATE ISSUED

'l/15/2017 2/15/2017

PAGE5 0 F9 PAGES




(301)594 - 4 695 Fax : (301)594 - 4 715 3004 135191





Specifica lly, your firm fa iled to update the~b) rt) I (VersaCut +) Design and Development PlanJ t>f(4~, effective date 04/ 05/ 2011, as the design and development milestones and the responsibilit ies for implementation evolved.

OBSERVATION 8 A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.

Specifica lly, your firm fa iled to conduct the process validation of the Versa Cut+ (plus) {6TT4~ ording to the VersaCut+ (plus) validation plan, effective date 10/ 29/ 2013. The plan states the ~b) (4)

~b)(4) . It continues that a ll

I I

The VersaCut+ Process Validation Report~6) (4) I, effective date 12/ 25/ 2013 reported ~6) (4) I nonconformances. The va lidation team decided to approve the VersaCut+ process validation and to correct the

deviations/ nonconformances by~6f(4) 1- In Validation Report~b) {4}7, effective date 02/ 13/ 2014, the deviations/ nonconformances that occurred in Validation~6) (4 ) l were corrected.

However, Validation Report~6}121)7 reported~t>f(4n new deviations/ nonconformances. None of the{6)1 4)7

deviations/ nonconformances were corrected. The validation team approved the process validation fo r

VersaCut+, with no justificat ion, evidence, or reasons for the approval.

In addit ion, your fi rm's report for process validation of the VersaCut+[(t>) (4) I is inadequate. Process

Validation Report~6f(4)7 and Process Validation Reporti6) (4 )7 contain conflicting information on which {6f{4) I were used to manufacture

the VersaCut+.

AM ENDMENT 3







10903 New Hampshire Avenue Silver Spring, 20993 (301)594-4695 Fax: (301)594-4715


Tzipi (NMI ) Ozer-Armon, CEO FIRM NAME


1/30/2017-2/2/2017 FEI NUMBER

3004135191

STREET ADDRESS

Lumenis Limited 6 Hakidma St.,Yokneam Ind. Park CITY. STATE.ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED


OBSERVATION 9 Procedm es for finished device acceptance have not been adequately established.

Specifica lly,

a) You r firm's acne fi lter manufacturing work instruction, Doc No. 6)1211 , effective 8/15/16, requires {6f{4

. However, you r firm's drawing for t he acne fi lt er specifies{6J (41 -----. Additionally, your fi rm does not keep a record of this testing.

c) The DHR for the VeraCut+[ 6) 4) does not require documentation of

whether t he test passed of failed, resulting in failure to document pass/fail for~D) (4) -----------s er i a I numbers reviewed.

OBSERVATION 10 Procedm es for acceptance of incoming product have not been adequately established .

Specifica lly, your firm receives 6J 4) from a (6) (4) {o)l4 _ T_h_e_d-ra-wing specifies b) (4)

. 6) 4) performs

(b) (4) provides(b) (4) The b) (4) reviewed appear to have (b) (4) ---------. Addit iona lly, one receiving document indicated b) (4) --------

----------------- . These products were accepted; however, justification for accepting product out of specification was not documented.


FORM FDA 483 (09/08)

AMENDM ENT 3


Cynthia L Gorveatt, Investigator Donna L Besone, Investigator


DATE ISSUED

'l/15/2017 2/15/2017

PAGE7 0 F9 PAGES





Tzipi (NMI ) Ozer-Armon, CEO FIRM NAME


1/30/2017-2/2/2017 FEI NUMBER

3004135191

STREET ADDRESS

Lumenis Limited 6 Hakidma St.,Yokneam Ind. Park CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED


OBSERVATION 11 Quality audits were not perfonned at defined intervals and at sufficient frequency to detennine whether the quality system activities and results comply with quality system procedures.

Specifically, your firm's implementation of your quality audit procedure, Local Quality Audit Process D) (4) and Global Audit Procedure (6) (4) , which requires that (6) (4) -------------------, is inadequate. For example, you r firm failed t o: --. - (6){4

• (b) (4)

In addit ion, your fi rm's 2016 interna l audit plan requires (b) rt) .----=================.--. However, t o date only (o)l.i:J --------------------OBSERVATION 12 Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been adequately established.

Specifica lly, your firm failed to ident ify product during the distribution stage. For example, distribut ion records for VersaCut + (plus) aREil the HeFu,wt (Fe§wlaF) {D) (4) shipped without a 6) (4) lacked t he

identifying serial number (S/N).

Observation 1 : Observation 2: Observation 3: Observation 4: Observation 5: Observation 6:


FORM FDA 483 (09/08)

Annotations to Observations Promised to coITect Promised to coITect Promised to coITect Promised to coITect Promised to coITect Promised to coITect

AM ENDMENT 3




DATE ISSUED

'l/15/2017 2/15/2017

PAGE8 0 F9 PAGES





Tzipi (NMI) Ozer-Armon, CEO FIRM NAME


1/30/2017-2/2/2017 FEI NUMBER

3004135191

STREET ADDRESS

Lumenis Limited 6 Hakidma St.,Yokneam Ind. Park CITY. STATE. ZIP CODE. COUNTRY

Yokneam, 20692Israel

Observation 7: Observation 8: Observation 9: Observation 10: Observation 11 : Observation 12:

Promised to coITect Promised to coITect Promised to coITect Promised to coITect Promised to coITect Promised to coITect


TYPE ESTABLISHMENT INSPECTED

Medical Device Manufacturer

AM ENDMENT 3



'l/15/2017

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS

DATE ISSUED

2/15/2017

PAGE90F9 PAGES

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