Directions for Use           Important Safety Information    

RevitaLens OcuTec® Multi-Purpose Disinfecting Solution


Peroxide-quality disinfection.
Multi-Purpose Disinfecting Solution convenience.

Advanced Science Takes Disinfection to a Higher Level

  • Abbott Medical Optics Inc. collaborated with world-class experts on this truly unique, next generation MPDS
  • Over 600 eye care professionals contributed to our research, enabling us to effectively understand and respond to their needs
  • The result is a high-performance formula that delivers quality disinfection compatible with Silicon Hydrogel and conventional soft contact lenses

For Greater Reliability, and Practitioner and Patient Assurance

  • Broad-spectrum disinfection comparable to disc peroxide systems1
  • Sustains antimicrobial activity even under non-compliant conditions2
  • Highly effective against Acanthamoeba1
  • Low rates of corneal staining and adverse events3,6
  • Highly effective protein removal for a variety of SiHy and soft contact lenses5
  • Excellent lens cleaning and compatibility3,4
  • Conditions the lenses7
  • Increases ocular comfort3,5

References:
  1. Kilvington S, Nikolic M, Lam A, Brady N, Lonnen J, Heaselgrave W. Antimicrobial efficacy of contact lens care solutions and a new experimental multi-purpose formulation against bacteria, fungi and Acanthamoeba. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  2. Powell H, Hoong L, Kilvington S, Lam A, Lonnen J. Evaporation effects on the efficacy of contact lens multi-purpose solutions. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  3. Tarantino N, Kao EY, Huang LC, Ziegler DA. A clinical safety and acceptability evaluation of a novel multi-purpose disinfecting solution. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  4. Huang LC, Agarwal A, Crawford L. In vitro biocompatibility assessment of contact lens multi-purpose solutions with silicone hydrogel lenses. Poster presented at: Association for Research in Vision and Ophthalmology (ARVO) Annual Conference; May 2-6, 2010; Fort Lauderdale, FL.
  5. Data on file - 103, 2010. Abbott Medical Optics Inc. Santa Ana, CA.
  6. Tilia D, Lazon de la Jara P, Weng R, Naduvilath T, Willcox M, Holden B. Clinical evaluation of a new contact lens solution when used in conjuction with two silicone hydrogel lenses during short term wear. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  7. Data on file -112, 2010. Abbott Medical Optics Inc. Santa Ana, CA. Wettability of Hydrogel Contact Lenses (RevitaLens OcuTec™ MPDS).

Unique formula provides Intelligent Disinfection

The OcuTec™ Activity of RevitaLens OcuTec™ MPDS is an interactive system consisting of disinfecting and buffering agents.

  • Conditions lenses1
  • Increases ocular comfort2
  • Delivers outstanding disinfection and sustained antimicrobial efficacy3,4

Intelligent disinfection for greater reliability, and practitioner and patient assurance.

References:

  1. Data on file -112, 2010. Abbott Medical Optics Inc. Santa Ana, CA. Wettability of Hydrogel Contact Lenses (RevitaLens OcuTec™ MPDS).
  2. Tarantino N, Kao EY, Huang LC, Ziegler DA. A clinical safety and acceptability evaluation of a novel multi-purpose disinfecting solution. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  3. Data on file - 103, 2010. Abbott Medical Optics Inc. Santa Ana, CA. 3. Kilvington S, Nikolic M, Lam A, Brady N, Lonnen J, Heaselgrave W. Comparative Antimicrobial efficacy of contact lens care solutions. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  4. Powell H, Hoong L, Kilvington S, Lam A, Lonnen J. Evaporation effects on the efficacy of contact lens multi-purpose solutions. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
Peroxide-quality disinfection with fewer complications

RevitaLens OcuTec™ MPDS delivers broad-spectrum disinfection comparable to disc peroxide1

99.99% biocidal efficacy against standard panel microorganisms1
Meets all requirements of ISO/ANSI/FDA biocidal and regimen efficacy.
* Bacteria = 3 log * Fungi = 1 log

Deliver greater patient safety from emerging pathogens2,4

RevitaLens OcuTec™ MPDS delivers superior antimicrobial efficacy against clinical isolates to meet the challenges posed by emerging pathogens and patient noncompliance.2,4

Highly effective against Acanthamoeba1

RevitaLens OcuTec™ MPDS is highly effective (>99.9%) against Acanthamoeba trophozoites and resistant cyst stage vs. OPTI-FREE® RepleniSH® MPDS and Biotrue™ MPS.1

Sustains antimicrobial activity even under non-compliant conditions3

RevitaLens Ocutec™ MPDS Sustains antimicrobial activity even under non-compliant conditions such as "topping off" of solutions, as well as failing to recap lens cases during soaking, which results to evaporation. Other solutions like OPTI-FREE® ReplesniSH® MPDS and Biotrue® MPS lost their efficacy after evaporation.3

OPTI-FREE® RepleniSH® MPDS efficacy was significantly reduced by 72% (P<0.05) against C. albicans and F. solani and 61% (P<0.05) loss against A.castellani. Biotrue™ MPS efficacy was significantly reduced by 48% (P<0.05) against C. albicans (data not shown).3

References:

  1. Kilvington S, Powell H, Lam A, Nikolic M, Brady N. Antimicrobial Properties of a New Multi-Purpose Contact Lens Disinfectant Solution. Poster, American Academy Optometry. Nov. 17-19, 2010. San Francisco, CA.
  2. Lonnen J. Efficacy of RevitaLens OcuTec™ MPDS against clinical microbial isolates. Report submitted: February 2010; University of Leicester, UK.
  3. Powell H, Hoong L, Kilvington S, Lam A, Lonnen J. Evaporation effects on the efficacy of contact lens multi-purpose solutions. Poster presented at: American Academy of Optometry; Nov. 17-19, 2010, San Francisco, CA.
  4. Data on file - 102, 2010. Abbott Medical Optics Inc. Santa Ana, CA. Biocidal efficacy of RevitaLens OcuTec™ MPDS against ISO 14729 test organisms.
Low corneal Staining and Adverse Events

Significantly lower rate of solution-induced corneal staining (SICS*)1


(*Defined as staining in 4 out of 5 zones among both lenses)

Fewer problems equal fewer patient dropout2


  5 AEs reported by 2.8% (5/177) of subjects using RevitaLens OcuTec™ MPDS over 3 months
17 AEs reported by 11.8% (11/93) of subjects using OPTI-FREE® RepleniSH® MPDS over 3 months

References:

  1. Tilia D, Lazon de la Jara P, Weng R, Naduvilath T, Willcox M, Holden B. Clinical evaluation of a new contact lens solution when used in conjuction with two silicone hydrogel lenses during short term wear. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  2. Tarantino N, Kao EY, Huang LC, Ziegler DA. A clinical safety and acceptability evaluation of a novel multi-purpose disinfecting solution. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
Excellent cleaning and increased ocular comfort

Highly effective protein removal for a variety of SiHy and soft contact lenses1

Excellent lens cleaning2

Excellent end of day comfort

RevitaLens OcuTec™ MPDS offers excellent lens wearing comfort at insertion and end of day3

Excellent comfort over time

RevitaLens OcuTec™ MPDS offers excellent lens wearing comfort over time4

References:

  1. Tarantino N, Kao E. A Six-Month Clinical Evaluation of the Safety and Acceptability of a Novel Multi-Purpose Disinfecting Solution. Poster presented at: American Academy of Optometry; Nov. 17-19, 2010, San Francisco, CA.
  2. Tarantino N, Kao EY, Huang LC, Ziegler DA. A clinical safety and acceptability evaluation of a novel multi-purpose disinfecting solution. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  3. Tilia D, Lazon de la Jara P, Weng R, Naduvilath T, Willcox M, Holden B. Clinical evaluation of a new contact lens solution when used in conjuction with two silicone hydrogel lenses during short term wear. Poster presented at: British Contact Lens Association's 34th Clinical Conference and Exhibition; May 27-30, 2010; Birmingham, UK.
  4. Data on file -104, 2010. Abbott Medical Optics Inc. Santa Ana, CA. Contact lens comfort with RevitaLens OcuTec™ MPDS over time.
Less toxic on patients’ eyes

RevitaLens OcuTec™ MPDS is less cytotoxic than OPTI-FREE® RepleniSH® MPDS1,2

OPTI-FREE® RepleniSH® MPDS and OPTI-FREE® Express® MPDS demonstrated the highest human corneal epithilial cell cytotoxicity with grades 3-4. RevitaLens OcuTec™ MPDS showed less cytotoxicity with grades 0-2 for all soft contact lens combinations (Figure 1)1.

RevitLens OcuTec™ MPDS Maintains better cell viability and barrier function than OPTI-FREE® RepleniSH® MPDS1

OPTI-FREE® RepleniSH® MPDS and OPTI-FREE® Express® MPDS induced significant loss of cell viability at 30min (see figure below). Soft contact lenses, including SiHy lenses, are least compatible with OPTI-FREE® RepleniSH® MPDS. RevitaLens OcuTec™ MPDS did not induce significant loss of cell viability compared to the media and PBS controls.

References:

  1. Huang L, Agarwal A, Crawford L. In vitro Biocompatibility Assessment of Contact Lens Multi-purpose Solutions with Silicone Hydrogel Lenses. Poster, Association for Research in Vision and Ophthalmology meeting. May 2-6, Fort Lauderdale, FL.
  2. Kilvington S, Huang L, Kao E, Powel H. Development of a new contact lens multipurpose solution: Comparative analysis of microbiological, biological and clinical performance. Journal of Optometry, Vol. 3, No.3, 134-142, June 2010.
Information for consumers

For consumer information on AMO's corneal care products please visit

RevitaLens OcuTec® Multi-Purpose Disinfecting Solution
Cleans, Rinses, Disinfects, Removes Protein, Stores and Conditions soft (hydrophilic) contact lenses, including silicone hydrogel lenses - All Steps in One Bottle.

INDICATIONS (Uses)
RevitaLens OcuTec® Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product, as recommended by your eye care practitioner, to:

  • Chemically (NOT HEAT) Disinfect
  • Clean
  • Rinse
  • Store
  • Remove Protein
  • Condition

CONTRAINDICATIONS (Reasons not to use)
Do not use if you are allergic to any ingredient in this product.

WARNINGS
PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD
RESULT IN CORNEAL INFECTION AND/OR ULCER AND LEAD TO LOSS OF VISION. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use of lenses and lens care products, including the lens case.

You should follow the complete recommended lens rubbing and rinsing times in the product labeling to adequately disinfect your lenses and reduce the risk of contact lens contamination. Reduced rubbing or rinsing times may not adequately clean your lenses.

You should fill your lens case with fresh solution every time your store your lenses and never “top-off” or re-use the solution.

You should discard your solution immediately after you lenses have been removed from the lens case.

You should not expose or store your lenses in or rinse your lens case with any water, such as tap, bottled, distilled, or with any non-sterile solution.

Clean, rinse and air dry your lens case each time you remove your lenses. In order to permit excess solution to drain, you can flip your lens case while air drying.

Replace your lens case frequently, depending on your hygiene habits.

Daily-wear lenses are not indicated for overnight wear and should not be worn while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when these lenses are worn overnight.

Extended-wear lenses should be regularly removed for cleaning and disinfection or for disposal and replacement on the schedule prescribed by your eye care practitioner. Clinical studies have shown that there is an increased incidence of serious adverse reactions in extended-wear contact lens users as compared to daily-wear contact lens users. Studies have also shown that the risk of serious adverse reactions increases the longer extended-wear lenses are worn before removal for cleaning and disinfection or for disposal and replacement.

Studies have also shown that smokers had a higher incidence of adverse reactions.

It is recommended that contact lens wearers see their eye care practitioner at least once a year or, if directed, more frequently.

To avoid contamination, do not touch the tip of the RevitaLens OcuTec® Multi-Purpose Disinfecting Solution bottle to any surface. Replace cap after using.

EXPIRATION / DISCARD DATE
Use the solution before the expiration date marked on the outer carton and bottle. Once the bottle is opened, discard any remaining solution after 90 days.

PRECAUTIONS

  • Avoid exposure to water when wearing and caring for your contact lenses.
  • Discard any remaining solution in your lens case before re-disinfecting. Always use fresh solution.
  • Rinse lens case and caps with fresh solution after each use; dry upside down on a clean towel. Do not use non-sterile water to rinse lens case.
  • Always wash your hands, and then dry with a clean, lint-free towel before handling lenses.
  • Keep bottle tightly closed when not in use.
  • Use the included AMO lens case with RevitaLens OcuTec® Multi-Purpose Disinfecting Solution.
  • Replace your AMO lens case every 1-3 months.
  • Store at room temperature.
  • Use before the expiration date marked on the bottle and carton.
  • Never use RevitaLens OcuTec® Multi-Purpose Disinfecting Solution with a heat disinfection unit.
  • Keep out of the reach of children.

ADVERSE REACTIONS (Problems and what to do)
The following problems may occur: eyes sting, burn or itch (irritation); comfort is less than when lens was first placed on the eye; feeling of something in the eye (foreign body, scratched area); excessive watering (tearing) of the eye; unusual eye secretions; redness of the eye; reduced sharpness of vision (poor visual acuity); blurred vision; rainbows or halos around objects; sensitivity to light (photophobia); or dry eyes. If you notice any of the above:

IMMEDIATELY REMOVE YOUR LENSES

  • If the discomfort or problem stops, then look closely at the lens
  • If the lens is in any way damaged, DO NOT put the lens back on your eye. Place the lens in the AMO lens case and contact your eye care practitioner.
  • If the lens has dirt, an eyelash, or other foreign body, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it.
  • If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner.

If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.

RevitaLens OcuTec® Multi-Purpose Disinfecting Solution