Alcon Research Recalls

Hazard: The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.

Hazard: Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.

Hazard: The product has potential to leak beyond their design specification.

Hazard: The product has potential to leak beyond their design specification.

Hazard: The product has potential to leak beyond their design specification.

Hazard: Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.

Hazard: The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

Hazard: Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.pdf) or exported surgical plans.

Hazard: Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.

Hazard: Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.

Hazard: The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.

Hazard: Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.

Hazard: There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

Hazard: Insufficient seal on the outside packaging, potentially affecting the sterility of the product.

Hazard: The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.

Hazard: The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

Hazard: Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.

Hazard: The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.

Hazard: Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle

Hazard: This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.