Alcon Laboratories, Inc.

Certificate G12 020895 0403

Rev. Rev. 02Withdrawn

Valid until: Dec 5, 2029

Certificate G12 020895 0403, a Quality management system issued to Alcon Laboratories, Inc., has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: G12 020895 0403
Certificate type: Quality management system
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0123G12 020895 0403Rev. 02

Validity

Issued: Jul 4, 2025
Valid from: Jul 4, 2025
Valid until: Dec 5, 2029

Manufacturer

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

: No
: No
: No
: No
: No
: No
: No
: Yes
: No
: No
: No
: No

History

Status changes

Withdrawn

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb10

10 scopes

P030102 - IOLs, APHAKIC Intended Purpose: Aspheric posterior chamber hydrophobic acrylic intraocular lens is intended to be placed in the capsular bag of the eye replacing the cataractous human crystalline lens,the Pre-loaded Delivery system provides a means to fold and insert the IOL into the capsular bag.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric posterior chamber hydrophobic acrylic intraocular lens is intended to be placed in the capsular bag of the eye replacing the cataractous human crystalline lens.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric extended depth of focus hydrophobic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing an extended range of vision from distance to functional near without increasing the incidence of visual disturbances.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric extended depth of focus hydrophobic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing an extended range of vision from distance to functional near without increasing the incidence of visual disturbances; the Pre-loaded Delivery System provides a means to fold and insert the IOL into the capsular bag.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric extended depth of focus toric hydrophobic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing an extended range of vision from distance to functional near without increasing the incidence of visual disturbances.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric extended depth of focus toric hydrophobic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing an extended range of vision from distance to functional near without increasing the incidence of visual disturbances; the Pre-loaded Delivery System provides a means to fold and insert the IOL into the capsular bag.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric triofcal hydrophobiic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing distance, intermediate and near vision with increased spectale independence; the Pre-loaded Delivery System provides a means to fold and insert the the IOL into the capsular bag.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric triofcal toric hydrophobiic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing distance, intermediate and near vision with increased spectale independence.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric triofcal toric hydrophobiic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing distance, intermediate and near vision with increased spectale independence; the Pre-loaded Delivery System provides a means to fold and insert the the IOL into the capsular bag.
Class IIb
P030102 - IOLs, APHAKIC Intended Purpose: Aspheric triofcal hydrophobiic acrylic intraocular lens intended to be placed in the capsular bag of the eye replacing the clear or cataractous human crystalline lens, providing distance, intermediate and near vision with increased spectale independence.
Class IIb

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