FDA.reportPublic FDA data

Boston Keratoprosthesis Lucia type I with anodized back plate

Primary DI
00086239500214
Brand
Boston Keratoprosthesis Lucia type I with anodized back plate
Company
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
Model
L-T1A
Catalog number
L-T1A
Device description
Boston Keratoprosthesis Type I Lucia with anodized back plate 7.8 mm Brown ( BR); Blue ( BL).
Published
2021-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQMKeratoprosthesis, Permanent Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQMKeratoprosthesis, Permanent ImplantOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00086239500214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00086239500214000862395002140862395002140086239500214

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
617 573 4129kpro_service@meei.harvard.edu

Regulatory Flags#

DUNS number
073825945
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862395000214Boston Keratoprosthesis Lucia Type I L-T1AL-T1A2021-10-04
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
00862395000214Boston Keratoprosthesis Lucia Type I Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.HQM2021-10-04
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