(1) (2) Portable surgical microscope and surgical microscope

Radiotherapy / Radiation protection

Carl Zeiss: 611P CT Lucia

Intense intraocular alert-carl zeiss

Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.

Ophthalmic Devices

1

No

Nationwide distribution including Puerto Rico.

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. || Used to fold and insert the firm's IOL's.

ophthalmological technology

medical_device

medical_device

430037-9000-000, 430037-9010-000, 430037-9020-000, 430037-9000-000, 430037-9010-000, 430037-9020-000, 430037-9030-000, 430037-9040-000 und 430037-9050-000

IVD: Microscope, general-purpose

Model Catalog: 430037-9020-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9050-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9041-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9000-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9031-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9030-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9010-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 430037-9040-000 (Lot serial: >10 NUMBERS CONTACT MFG)

AXIO LAB.A1 MICROSCOPE

Model Catalog: CALLISTO EYE 3.0 (Lot serial: 7028210); Model Catalog: CALLISTO EYE 3.1 (Lot serial: 7028209); Model Catalog: CALLISTO EYE 3.0 (Lot serial: 7028209); Model Catalog: CALLISTO EYE 3.1 (Lot serial: 7028208); Model Catalog: CALLISTO EYE 3.0 (Lot serial: 7028208); Model Catalog: CALLISTO EYE 3.1 (Lot serial: 7028210)

Callisto Eye 3.0 and 3.1

Model: Product Code: NFJ, Affected: , Software version: V 3.2.1

Model: 000000-1692-983, Affected: , Software version: 7.5.2, 7.7.2 and 7.7.3

Model: 000000-1692-983; 1789-811, 1322-734, 1262-306, 1262-307, 9004-00, 1064-064 and 1134-078, Affected:

Carl Zeiss Meditec AG

All units manufactured are subject to correction.

Not Classified

No

Worldwide Distribution -- USA (nationwide)

Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. || The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.

Model: , Affected: Manufactured from December 8, 2006 to October 5, 2010

Carl Zeiss VisuMax Laser Keratome, Carl Zeiss Meditec AG

Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)

Carl Zeiss