Please use local template for business letters

FIELD SAFETY CORRECTIVE ACTION

JEN FCA 2020-005, Laser Safety Eyeglasses for 532/561 and for YAG,
Mislabeling of Laser Safety Eyeglasses
Dear Valued Customer,

Our records indicate that you own Laser Safety Eyeglasses for 532/561 and/or for YAG. Thank you for be-
ing a valued customer of ZEISS. High quality and innovation are our main goals, however reliability and
customer satisfaction are our priorities.
This letter is to inform you about a Field Safety Corrective Action (FSCA) concerning Laser Safety Eye-
glasses for VISULAS 532s and YAG III, with the aim to remove incorrect labeled Laser Safety Eyeglasses.

Problem description:
Based on post market surveillance activities we found that the outside packaging of Laser Safety Eye-
glasses was labeled with an incorrect product identification.
Laser Safety Eyeglasses labeled as "Safety laser eyewear for YAG" (REF-Number: 000000-0450-052)
may contain the Laser Safety Eyeglasses "Safety eyeglasses 532/561" (REF-Number: 000000-0496-371)
and vice versa.

For further details please see illustration on page 3-5 of this letter.

Hazard involved:
Protective eyewear in the form of appropriately filtering optics protects the eyes from the reflected or
scattered laser light with a hazardous beam power, as well as from direct exposure to a laser beam. The

Chairman of the Supervisory Board:
Dr. Michael Kaschke
Address of Record: Deutsche Bank Jena
Goeschwitzer Str. 51-52 Account: 624536900 (BIC 820
700 00)
07745 Jena, Germany S.W.I.F.T.-Code: DEUT DE 8EXXX
Tel.: +49 36 41 220-0 IBAN:
DE90820700000624536900
Commercial Register:
Local Court Jena HRB 205623
VAT-ID. No. DE 811 922 737
WEEE-Reg.-Nr. DE55298748

Board of Management: Address for Delivery: Commerzbank Jena

Dr. Ludwin Monz, President and
CEO
Justus Felix Wehmer (CFO)
Jan Willem de Cler
Carl Zeiss Meditec AG Account: 258072800 (BIC 820
400 00)
Carl-Zeiss-Promenade 10 S.W.I.F.T.- Code: COBADEFFXXX
07745 Jena, Germany IBAN:
DE31820400000258072800
 Page 2 of 2

laser safety glasses YAG (REF-Number: 000000-0450-052) reduce beam power in the UV and NIR range
and is typical used for medical lasers with 1064 nm working beam (VISULAS YAG family). The laser safety
glasses 532/561 (REF-Number: 000000-0496-371) reduce beam power in the UV and VIS (532 nm / 561
nm) range and is typical used for medical lasers with 532 nm (VISULAS 532 family and VISULAS green
family) and 561 nm working beam.
The safety glasses for 532 nm (REF-Number: 000000-0496-371) do not have enough protection for near-
infrared (NIR) laser radiation (VISULAS YAG family), and the NIR (1064 nm) safety glasses (REF-Number:
000000-0450-052) do not have enough protection for 532 nm laser radiation. Due to this fact there is a
likelihood of injury to users or third parties if wrong glasses are used for the application. The probability
of injury is unlikely but possible. If the wrong shield is used the customer is not protected against the laser
beam which can result in a serious damage to the eye.

Affected products:
Laser Safety Eyeglasses "Safety laser eyewear for YAG" (REF-Number: 000000-0450-052) and "Safety
eyeglasses 532/561" (REF-Number: 000000-0496-371) delivered between December 10, 2019 to March
12, 2020 may be affected.

Actions to be taken:
To correct this issue, it is required that you replace your Laser Safety Eyeglasses with incorrect product
identification by a new one. Kindly fill in the “Acknowledgement and Receipt Form” which is attached
along with this letter and confirm completion (s. attachment 1). Please state whether your Laser Safety
Eyeglasses are affected by wrong labeling.
Return the “Acknowledgement and Receipt Form” along with your incorrect labeled Laser Safety Eye-
glasses to the local ZEISS organization. A new replacement Laser Safety Eyeglasses will be provided to
you free of charge.
If you have any questions, please contact your local representative and ask for support.

We thank you very much for your careful attention to this matter and for putting your trust in ZEISS. We
apologize for any inconvenience this situation might cause. We will do our best to address your individual
needs and concerns.

Best regards

Carl Zeiss Meditec AG

 Page 2 of 2

Illustration:

1. Example Laser Safety Eyewear for YAG: incorrect correct

 Page 2 of 2

2. Example Laser Safety Eyewear for 532: incorrect correct

 Page 2 of 2

3. Different material description by supplier NoIR and Carl Zeiss Medi-

tec

Supplier NoIR Meditec Material

Description Color of safety Material No. Description in SAP
eyeglass
YG3#33 green 000000-0450-052 Laser safety eyeglasses YG3#33

ZS2 red 000000-0496-371 Laser safety eyeglasses 532/561 DIN EN

207