Aberrometer, Ophthalmic
Ophthalmic · 21 CFR 886.1760
Recent MDR events
649 adverse event reports on file
- ORA System with VerifEye MessagingJul 28, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01156
- ORA SYSTEM WITH VERIFEYE MESSAGINGJul 22, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01116
- ORA SYSTEM 2000Jul 22, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01124
- ORA SYSTEM WITH VERIFEYE MESSAGINGJul 14, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01046
- ORA SYSTEM 2000Jul 13, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01044
- ORA SYSTEM 2000Jul 3, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00973
- ORA SYSTEM WITH VERIFEYE MESSAGINGJul 2, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-00952
- ORA SYSTEM WITH VERIFEYE MESSAGING, CARTJul 2, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-00956
- ORA SYSTEM WITH VERIFEYE MESSAGINGJul 2, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-00959
- ORA SYSTEM WITH VERIFEYE MESSAGINGJul 2, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-00960
Event type breakdown
Recalls
2 recall events for this product code
- Alcon Research, Ltd.TerminatedUnknown
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
Z-3049-2017 · View FDA record ↗ - Alcon Research, Ltd.TerminatedUnknown
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
Z-3050-2017 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Technolas Perfect Vision Gmbh
Munchen Bavaria, DE
Bausch & Lomb Incorporated
Rochester, NY, US
Tracey Technologies, Corp.
HOUSTON, TX, US
Wavelight Gmbh
PRESSATH Bavaria, DE
Alcon Research, Llc
Lake Forest, CA, US
Alcon Research, Llc
IRVINE, CA, US
Ovitz Corporation
Rochester, NY, US
Bausch & Lomb Incorporated
Saint Louis, MO, US
Wavelight Gmbh
ERLANGEN Bavaria, DE
Wavefront Dynamics, Inc.
Albuquerque, NM, US
Vmax Vision Inc.
Longwood, FL, US
510(k) clearances
4 clearances for this product code
- Alcon Research, Ltd.Nov 8, 2006
K062930 · LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
- Nidek, Inc.Aug 24, 2005
K050336 · OPD-STATION SOFTWARE
- Alcon Laboratories, Inc.Oct 18, 2002
K023249 · ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
- Alcon Laboratories, Inc.May 19, 2000
K000637 · CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)