FDA.reportPublic FDA data

ACURUS

Primary DI
M454AR120P1251
Brand
ACURUS
Company
EYEKON MEDICAL, INC.
Model
AR120-12.5
Device description
POSTERIOR CHAMBER INTRAOCULAR LENS
Published
2015-09-18
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

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880072000MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOLEyekon Medical, Inc.1989-09-22HQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M454AR120P1251PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803926252
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
U400DP3001ISOTECHNICSU400D-30.02015-09-18
M454AR120P0401ACURUSAR120-04.02015-09-18
M454AR120P0451ACURUSAR120-04.52015-09-18
M454AR120P0501ACURUSAR120-05.02015-09-18
M454AR120P0551ACURUSAR120-05.52015-09-18
M454AR120P0601ACURUSAR120-06.02015-09-18
M454AR120P0651ACURUSAR120-06.52015-09-18
M454AR120P0701ACURUSAR120-07.02015-09-18
M454AR120P0751ACURUSAR120-07.52015-09-18
M454AR120P0801ACURUSAR120-08.02015-09-18
M454AR120P0851ACURUSAR120-08.52015-09-18
M454AR120P0901ACURUSAR120-09.02015-09-18
M454AR120P0951ACURUSAR120-09.52015-09-18
M454AR120P1001ACURUSAR120-10.02015-09-18
M454AR120P1051ACURUSAR120-10.52015-09-18
M454AR120P1101ACURUSAR120-11.02015-09-18
M454AR120P1151ACURUSAR120-11.52015-09-18
M454AR120P1201ACURUSAR120-12.02015-09-18
M454AR120P1301ACURUSAR120-13.02015-09-18
M454AR120P1351ACURUSAR120-13.52015-09-18

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