FDA.reportPublic FDA data

Boston Keratoprosthesis Lucia Type I

Primary DI
00862395000214
Brand
Boston Keratoprosthesis Lucia Type I
Company
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
Model
L-T1A
Catalog number
L-T1A
Device description
Boston Keratoprosthesis Lucia Type 1 Aphakia with anodized Titanium back plate 7.8 mm BR (Brown ); BL (Blue)
Published
2021-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQMKeratoprosthesis, Permanent Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQMKeratoprosthesis, Permanent ImplantOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182986000Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston2019-01-30HQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862395000214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862395000214008623950002148623950002140862395000214

GMDN Terms#

Term, Definition table
TermDefinition
Cornea prosthesisAn implantable artificial substitute for a natural cornea used to improve/restore the vision of an adult patient with corneal opacity. Also known as a keratoprosthesis, this is usually a two-component device made of, e.g., poly 2-hydroxyethylmethacrylate (PHEMA), one component being a small fine threaded flange that is attached to the anterior of the eye and the other being the lens, which is a solid cylinder of this material, threaded at the distal end and convex at the proximal end. This lens is threaded into the flange proving the user with a window through which he or she can see. This device may be used when other interventions are not possible.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073825945
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00086239500214Boston Keratoprosthesis Lucia type I with anodized back plateL-T1AL-T1A2021-08-13
00862394000208Boston Keratoprosthesis Snap-on TypeISOF-TI5ASOF-TI5A2015-10-29
00862394000215Boston Keratoprosthesis Snap-on TypeISOF-T15PSOF-T15P2015-10-30
00862394000222Boston Keratoprosthesis Snap-on TypeISO-8.5SO-8.52015-10-30
00862394000239Boston Keratoprosthesis Snap-on TypeISO-7SO-72015-10-30
00862394000246Boston Keratoprosthesis Snap-on TypeITSO-8.5TSO-8.52015-10-30
00862394000253Boston Keratoprosthesis Snap-on TypeITSO-7TSO-72015-10-30
00862394000260Boston Keratoprosthesis Snap-on Type ITSR-100TSR-1002015-10-30
00862394000277Boston Keratoprosthesis Click-on TypeICLF-IACLF-IA2015-10-30
00862394000284Boston Keratoprosthesis Click-on Type ICLF-IPCLF-IP2015-10-30
00862394000291Boston Keratoprosthesis Click-on Type IICLF-TIIACLF-TIIA2015-10-30
00862395000207Boston Keratoprosthesis Click-onType IICLF-TIIPCLF-TIIP2015-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086239500214Boston Keratoprosthesis Lucia type I with anodized back plateMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2021-08-13
00862394000215Boston Keratoprosthesis Snap-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000222Boston Keratoprosthesis Snap-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000239Boston Keratoprosthesis Snap-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000246Boston Keratoprosthesis Snap-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000253Boston Keratoprosthesis Snap-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000260Boston Keratoprosthesis Snap-on Type IMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000277Boston Keratoprosthesis Click-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000284Boston Keratoprosthesis Click-on Type IMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000291Boston Keratoprosthesis Click-on Type IIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862395000207Boston Keratoprosthesis Click-onType IIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-30
00862394000208Boston Keratoprosthesis Snap-on TypeIMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2015-10-29