Bausch & Lomb · Model Orbscan IIZ
Acquires over 9000 data points in 1.5 seconds. Analyzes elevation and curvature measurements on both anterior and posterior surfaces of the cornea. Capable of detecting and analyzing posterior corneal abnormalities where corneal anomalies first appear. Features dynamic, Windows-based platform designed to integrate continuing advances via upgradable software. Customizable quad maps show any combination of measurements in one convenient format. Slit scanning technology combined with an advanced placido disc system Anterior corneal elevation and curvature. Posterior corneal elevation and curvature. Full corneal pachymetry. Simulated keratometry. White-to-white diameter. Pupil size (mesopic) Anterior chamber depth. Angle kappa Irregularity index.
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Symptoms: Dim illumination, lamp error.
Root cause: Xenon/LED aging.
Symptoms: No phaco power, error.
Root cause: Tip or handpiece wear.
Symptoms: Unstable anterior chamber.
Root cause: Peristaltic pump wear.
Symptoms: Blurry/offset image.
Root cause: Camera calibration drift.
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Consumable.
High-value, track usage.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Peristaltic pump tubing Consumable. | Frequent wear item | $ | Easy |
| Imaging camera module | Periodic replacement | $$$ | Difficult |
| Phaco handpiece / tip High-value, track usage. | Periodic replacement | $$$$ | Difficult |
| Illumination lamp / LED | Periodic replacement | $$$ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
The back cap separates from the body of the vitrectomy cutter.
Product was found to contain excess residual levels of hydrogen peroxide.
The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.
Haptics breaking during lens loading and insertion.
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Out of specification results for one of the two disinfectants.
Lens was manufactured with incorrect raw material.
Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury.
Posterior fluidics modules installed in the system may need to be recalibrated.
The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
There is a potential for some packages to not meet sterility requirements.
The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens.
The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
During routine testing the product failed to meet shelf life specifications.
The product failed to meet one of the shelf life specifications at the end of the expiry period.
Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.
The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Reports have been received of stromal incursions after use of the product.
A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
The cutter probe tip breaks during use.
The cutter tip could break during a procedure
Reports of Fusarium Infections among contact lens wearers.
Portion of lot contains lenses with incorrect refractive power.
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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