International Medical Devices Database

Manufacturer Address
Ziemer Usa Inc, 620 East Third Street, Alton IL 62002
Manufacturer Parent Company (2017)
Ziemer Holding Ag
Source
USFDA
2 Events
- Recall of 1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6
- Recall of Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers

2 devices in the database

1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6

Model / Serial
Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
Product Description
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. || 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. || 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.

Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers

Model / Serial
Serial Numbers: FLM4184, FLM2003, FLM3324, FLM1409, FLM2906, FLM2136, FLM4948, FLM3134, FLM4587, FLM3281, FLM2179, FLM1467, FLM1239, FLM3361, FLM3319, FLM3685, FLM2915, FLM1230, FLM3229, FLM4094, FLM4135, FLM4545, FLM4905, FLM3913, FLM1680, FLM1776
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Product Description
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Ziemer Usa Inc

2 devices in the database

1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6

Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers