Recall Z-0811-2014— Ziemer Usa Inc
Class II · Terminated
Class II FDA medical device recall by Ziemer Usa Inc, initiated 2013-04-16, terminated 2017-12-27. It names one FDA 510(k) clearance: K112154. Product: 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.. Reason: A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off..
- Recalling firm
- Ziemer Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-16
- Terminated
- 2017-12-27
- Firm location
- Alton, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
Data sourced from openFDA. This site is unofficial and independent of the FDA.