FDA.reportPublic FDA data

SOFTEC HDO

Primary DI
00844369037013
Brand
SOFTEC HDO
Company
Lenstec Barbados Inc
Model
SOFTECHDO+6.0
Catalog number
SOFTEC HDO
Device description
IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
Published
2015-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P090022011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P090022011LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENSLenstec, Inc.2010-04-12HQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844369037013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844369037013008443690370138443690370130844369037013

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-536-7832feedback@lenstec.com

Regulatory Flags#

DUNS number
860235001
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844369016858I9011S05-21352024-05-06
00844369016865I901205-2136-B2024-05-06
00844369016872I9012FS05-2138-B2024-05-06
00844369018944LC16LC162024-05-06
00844369018968LC24LC242024-05-06
00844369018975CART45SCART45S2024-05-06
00844369018982CARTMCARTM2024-05-06
00844369038003ClearView 3SBL-3+10.0SBL-32023-01-25
00844369038010ClearView 3SBL-3+10.5SBL-32023-01-25
00844369038027ClearView 3SBL-3+11.0SBL-32023-01-25
00844369038034ClearView 3SBL-3+11.5SBL-32023-01-25
00844369038041ClearView 3SBL-3+12.0SBL-32023-01-25
00844369038058ClearView 3SBL-3+12.5SBL-32023-01-25
00844369038065ClearView 3SBL-3+13.0SBL-32023-01-25
00844369038072ClearView 3SBL-3+13.5SBL-32023-01-25
00844369038089ClearView 3SBL-3+14.0SBL-32023-01-25
00844369038096ClearView 3SBL-3+14.5SBL-32023-01-25
00844369038102ClearView 3SBL-3+15.0SBL-32023-01-25
00844369038119ClearView 3SBL-3+15.25SBL-32023-01-25
00844369038126ClearView 3SBL-3+15.5SBL-32023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658439668ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439675ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439682ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439699ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439705ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439712ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439729ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439736ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439743ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439750ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439767ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439774ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439781ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439798ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439804ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439811ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439828ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439835ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439842ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439859ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439866ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439873ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439880ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439897ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439903ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439910ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439927ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439934ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439941ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439958ClareonAlcon Laboratories, Inc.HQL2026-08-27