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IC-8 Apthera IOL

FDA UDI

Class III (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name
IC-8 Apthera IOL FDA UDI
Generic Name
Posterior-chamber intraocular lens, pseudophakic, extended-focus FDA UDI
Device Name
One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens. FDA UDI
Model / Reference
+16.0 D FDA UDI
Description
One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens. FDA UDI

Identifiers

Catalog Number
82078-160 FDA UDI
Primary DI / UDI-DI
00813359020854 FDA UDI
PMA Number
P210005 FDA UDI
FDA Product Code
POE FDA UDI
GMDN Term
Posterior-chamber intraocular lens, pseudophakic, extended-focus FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Posterior-chamber intraocular lens, pseudophakic, extended-focus

IC-8 Apthera IOL by Bausch & Lomb Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-chamber intraocular lens, pseudophakic, extended-focus.

Cleared under the same submission

P210005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated

Sources (1)

  • FDA UDI 41c9b06a-2940-41cc-a238-4142e31791c4 35 fields · synced Jun 8, 2026