Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015

Ophthalmic Devices

1

No

Distributed to Mexico only

Alcon Monarch III (1) "C" Cartridge || The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

Ophthalmic Devices

Ophthalmic Devices

Ophthalmic Devices

Medical Device Safety Alert: Alcon CyPass Micro-Stent

Lot numbers: 520522H, 511655H, and 489635H

Ophthalmic Devices

2

No

Lake Charles, LA

Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)

Lot Number: 8717082, Exp. 10/2013, Label Power: -0.50, Cylinder: -1.75, Axis: 180; and Lot Number: 8717066, Exp. 10/2013, Label Power: -2.50, Cylinder -1.75, Axis 180.

Ophthalmic Devices

3

No

Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI.

AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097. || Toric lenses approved for daily wear and extended wear up to 6 nights.

Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.

Ophthalmic Devices

1

No

Nationwide distribution including Puerto Rico.

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. || Used to fold and insert the firm's IOL's.

Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J; Vision Care Ireland

Ophthalmic Devices

3

No

Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

B007NV51 and B0077KM1.

Ophthalmic Devices

2

No

Nationwide.

Acuvue Advance for Astigmatism Diagnostic Product. || Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. || Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. || Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.

Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J; Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J; Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D

Ophthalmic Devices

2

No

Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

Ophthalmic Devices

ACCURUS Vitrectomy probesACCURUS 23GA Standalone Vitreous ProbeCatalog # 8065750821Lot number: 14017912XAnterior ACCURUS® Probe with infusion needle Catalog # 8065803650Lot numbers: 14010430X, 140174S1X, 14010430X, 14017451XARTG Numbers 140947 and 145666

Ophthalmic Devices

Ophthalmic Devices

Ophthalmic Devices

ophthalmological technology - liquid media for ophthalmological purposes

59051; 59081; 60081; 59051L; 59081L; 60051L; 60081L

Ophthalmic Devices

MD: Ophthalmic working-channel cannula, single-use

Lot #9013991X, 9014291X and 9014509X.

Ophthalmic Devices

1

No

Worldwide Distribution -- USA and Canada.

Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.

Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205

Ophthalmic Devices

1

No

Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens || For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817

Ophthalmic Devices

2

No

Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.

1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. || 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. || 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.

Lot B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J; Vision Care Inc. Jacksonville, FL

Ophthalmic Devices

2

No

Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses