FDAAugust 27, 2025device
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
What to do
FDA enforcement status: Ongoing
Brands named
vision rtvision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH2022025-08-18
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m2025-08-18
- FDAACUVUE¿ OASYS MAX 1-Day MULTIFOCAL2025-06-12
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only2024-10-16
- FDAJohnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.2024-03-14
- FDATECNIS Toric II OptiBlue IOL Models ZCW2023-12-12
- FDATECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only2023-07-06
- FDATECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only2023-07-06
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