LIQUID OPTICS INTERFACE LOI-12Recalls & reported problems
Optimedica Corporation · SINGLE LIQUID OPTICS INTERFACE,12 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604810), received between Mar 7, 2017 and Jul 18, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Unsealed Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2018Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED BY THE ACCOUNT THAT THE LIQUID OPTICS INTERFACE (LOI) PRODUCT WAS NOT SEALED WHEN PACKAGE WAS OPENED. THE PRODUCT WAS REQUESTED BUT IT WAS REPORTED THAT UNFORTUNATELY THEY DISPOSED IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7701225 ↗MalfunctionMar 7, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT AFTER OPENING THE LIQUID OPTICS INTERFACE (LOI) BOX AND INSIDE TRAY LABELED AS LOI-12 IT WAS FOUND THAT THE LOI INSIDE THE PACKAGE WAS A DIFFERENT PRODUCT SIZE: LOI-14. THIS OCCURRED PRIOR TO START OF THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6385275 ↗
Other Ophthalmic femtosecond laser devices
- LenSx 8065998162Alcon Laboratories, Inc. · Ophthalmic femtosecond laser599 reports
- CATALYS SYSTEM CATALYS-UOptimedica Corporation · Ophthalmic femtosecond laser576 reports
- WaveLight 8065990941Alcon Laboratories, Inc. · Ophthalmic femtosecond laser460 reports
- ALLY 70-00050-001LENSAR, Inc. · Ophthalmic Femtosecond Laser81 reports
- LIQUID OPTICS INTERFACE 0180-1201Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser51 reports
- ELITA EL2022Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser31 reports
- LIQUID OPTICS INTERFACE 0180-1401Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser28 reports
- CATALYS SYSTEM CAT PREC LSR SYSJohnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.