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Alcon Research
107 recalls • • Categories: Other Medical Devices, Implants & Prosthetics, Surgical Instruments, Compounded Drugs, Infusion Pumps +2 more
🏥 Medical Devices Class I - Dangerous
Potential for a weak seal in some units resulting in compromise in sterility.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
🏥 Medical Devices Class I - Dangerous
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
🏥 Medical Devices Class I - Dangerous
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
💊 Drugs Class I - Dangerous
Non-Sterility
🏥 Medical Devices Class I - Dangerous
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
🏥 Medical Devices Class I - Dangerous
Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
🏥 Medical Devices Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
🏥 Medical Devices Class I - Dangerous
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
🏥 Medical Devices Class I - Dangerous
Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
🏥 Medical Devices Class I - Dangerous
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Sterility; Steril surgical procedure packs contain incomplete seals.
🏥 Medical Devices Class I - Dangerous
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
🏥 Medical Devices Class I - Dangerous
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
🏥 Medical Devices Class I - Dangerous
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
🏥 Medical Devices Class I - Dangerous
Incorrect IOL diopter
🏥 Medical Devices Class I - Dangerous
There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
🏥 Medical Devices Class I - Dangerous
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
🏥 Medical Devices Class I - Dangerous
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
🏥 Medical Devices Class I - Dangerous
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
🏥 Medical Devices Class I - Dangerous
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
🏥 Medical Devices Class I - Dangerous
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
🏥 Medical Devices Class I - Dangerous
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
🏥 Medical Devices Class I - Dangerous
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.
🏥 Medical Devices Class I - Dangerous
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
🏥 Medical Devices Class I - Dangerous
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
🏥 Medical Devices Class I - Dangerous
Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.
🏥 Medical Devices Class I - Dangerous
The intraocular lens could become lodged within the cartridge
🏥 Medical Devices Class I - Dangerous
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
🏥 Medical Devices Class I - Dangerous
The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
The product has potential to leak beyond their design specification.
🏥 Medical Devices Class I - Dangerous
The product has potential to leak beyond their design specification.
🏥 Medical Devices Class I - Dangerous
The product has potential to leak beyond their design specification.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
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.
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.
🏥 Medical Devices Class I - Dangerous
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
🏥 Medical Devices Class I - Dangerous
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
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.
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.