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Ophthalmic Femtosecond Laser
FDA product code OOE · Class 2 · Ophthalmic
43
Registered devices
4,829
Adverse events
8
Recalls
47
510(k) clearances
Devices with this code
FEMTOLDV — SIE AG, Surgical Instrument EngineeringELITA — JOHNSON & JOHNSON SURGICAL VISION, INC.Procedure Pack Z8 — SIE AG, Surgical Instrument EngineeringProcedure Pack Z8 — SIE AG, Surgical Instrument EngineeringLLS/ALLY — LENSAR, Inc.ALLY — LENSAR, Inc.LLS/ALLY — LENSAR, Inc.Patient Interface 125 Kit — Technolas Perfect Vision GmbHPatient Interface 125 Kit — Technolas Perfect Vision GmbHCATALYS SYSTEM — OPTIMEDICA CORPORATIONProcedure Pack Z8 — SIE AG, Surgical Instrument EngineeringLENSAR LLS-fs 3D — LENSAR, Inc.LIQUID OPTICS INTERFACE — JOHNSON & JOHNSON SURGICAL VISION, INC.Procedure Pack Z8 — SIE AG, Surgical Instrument EngineeringProcedure Pack Z8 — SIE AG, Surgical Instrument EngineeringINTRALASE TECHNOLOGY PI — JOHNSON & JOHNSON SURGICAL VISION, INC.LIQUID OPTICS INTERFACE — OPTIMEDICA CORPORATIONLenSx — Alcon Laboratories, Inc.Procedure Pack Z8 — SIE AG, Surgical Instrument EngineeringProcedure Pack Z8 — SIE AG, Surgical Instrument EngineeringFEMTO — SIE AG, Surgical Instrument EngineeringVICTUS™ Femtosecond Laser Platform — Technolas Perfect Vision GmbHALLY — LENSAR, Inc.LIQUID OPTICS INTERFACE — OPTIMEDICA CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-10-21 | AMO Manufacturing USA, LLC | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabl |
| 2018-05-09 | Johnson & Johnson Surgical Vision Inc | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the i |
| 2018-01-21 | SIE AG, Surgical Instrument Engineering | This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An inv |
| 2016-04-14 | Alcon Research, Ltd. | Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, whi |
| 2015-02-20 | Optimedica Corporation | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both |
| 2015-02-20 | Abbott Medical Optics, Inc. | Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. |
| 2014-03-14 | Alcon LenSx, Inc. | Alcon LenSx received reports of unexpected downward motion of the gantry. |
| 2013-12-20 | Optimedica Corporation | Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, |
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