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Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic

FDA UDI

Class III (US FDA UDI)

by Staar Surgical Co.

Identity

Trade Name
Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic FDA UDI
Generic Name
Posterior-chamber intraocular lens, pseudophakic FDA UDI
Device Name
Diopter: 23.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 17.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 17.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 15.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 16.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 23.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 18.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 18.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Model / Reference
AA4203TL FDA UDI
Description
Diopter: 23.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 17.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 17.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 15.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 16.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 23.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 18.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Diopter: 18.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI

Identifiers

Primary DI / UDI-DI
00841542101219 FDA UDI
00841542100700 FDA UDI
00841542101080 FDA UDI
00841542100656 FDA UDI
00841542101066 FDA UDI
00841542100823 FDA UDI
00841542100717 FDA UDI
00841542101110 FDA UDI
PMA Number
P880091 FDA UDI
FDA Product Code
MJP FDA UDI
GMDN Term
Posterior-chamber intraocular lens, pseudophakic 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Posterior-chamber intraocular lens, pseudophakic

Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic by Staar Surgical Co. — Class III — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Posterior-chamber intraocular lens, pseudophakic.

Cleared under the same submission

P880091 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Staar Surgical Co.

Sources (8)

  • FDA UDI 59c9070e-3242-44d5-beee-113253adcbe6 34 fields · synced Jun 7, 2026
  • FDA UDI cd37e2c8-f678-4b86-8c13-b5a892c73f03 34 fields · synced May 25, 2026
  • FDA UDI 76909947-ac97-4d2a-8fa9-e2b28af20323 34 fields · synced May 25, 2026
  • FDA UDI 40d87082-923c-4afd-b98b-3c855d94cee4 34 fields · synced May 25, 2026
  • FDA UDI 23c1af70-ebb9-41b5-96ca-ec0f208a257d 34 fields · synced May 25, 2026
  • FDA UDI 0b1aae73-dcf0-4628-a8a0-420b0e3c1d1a 34 fields · synced May 25, 2026
  • FDA UDI 99a5124a-1d2b-4501-b7ea-b997283c2526 34 fields · synced May 27, 2026
  • FDA UDI 71f7b411-bc32-44a8-8c53-28da054313af 34 fields · synced May 27, 2026