Bausch & Lomb Spectronic 20

Documents & Manuals

• Bausch Lomb Spectronic-20 UserManualUser Manual · External
• - UserManualUser Manual · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

• RECALL

  The back cap separates from the body of the vitrectomy cutter.

• RECALL

  Product was found to contain excess residual levels of hydrogen peroxide.

• RECALL

  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.

• RECALL

  Haptics breaking during lens loading and insertion.

• RECALL

  A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

• RECALL

  Out of specification results for one of the two disinfectants.

• RECALL

  Lens was manufactured with incorrect raw material.

• RECALL

  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.

• RECALL

  Posterior fluidics modules installed in the system may need to be recalibrated.

• RECALL

  The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction

• RECALL

  There is a potential for some packages to not meet sterility requirements.

• RECALL

  The amount of D&C #6 Dye added to the formulation exceeded specified amounts.

• RECALL

  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.

• RECALL

  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.

• RECALL

  During routine testing the product failed to meet shelf life specifications.

• RECALL

  The product failed to meet one of the shelf life specifications at the end of the expiry period.

• RECALL

  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.

• RECALL

  The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.

• RECALL

  Reports have been received of stromal incursions after use of the product.

• RECALL

  A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.

• RECALL

  The cutter tip could break during a procedure

• RECALL

  Reports of Fusarium Infections among contact lens wearers.

• RECALL

  Portion of lot contains lenses with incorrect refractive power.

• RECALL

  The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.

• RECALL

  Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.

Related calculators

From BioLab, for work done with this kind of equipment.

• DNA and RNA ConcentrationNucleic acid concentration and purity from absorbance
• Calibration CurveLinear fit, residuals and an unknown with its uncertainty
• OD600 to Cell DensityEstimate bacterial cell density from optical density
• Bacterial Growth RateSpecific growth rate and doubling time