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11. Remove the viscoelastic material thoroughly from the eye and the lens with the
standard irrigation and aspiration techniques.
7. Important:
1. Physicians considering lens implantation under any of the conditions described herein
should weigh the potential benefit / risk ratio prior to implantation.
2. As with any surgical procedure, there is risk involved. A high level of surgical skill is
required for intraocular lens implantation. A surgeon should have observed and / or
assisted on numerous surgical implantations and successfully completed one or more
courses on intraocular lens implantation before attempting to implant intraocular lenses.
3. The requirement for a secondary iridectomy for pupillary block may be prevented
by one or more iridectomies at the time of IOL implantation. This preventative
measure is better known for anterior chamber and iris fixation models. It has also been
determined to apply to posterior chamber models.
4. Improper handling of this lens may cause damage to the haptics and the optics.
5. The long-term effects of intraocular lens implantation have not been determined.
Therefore, physicians should continue to monitor implant patients postoperatively.
8. Warnings:
1. DO NOT resterilize any component of the product.
2. To prevent the risk of infection, discard (scrap) device if not implanted. Reuse of an
explanted device could cause infection or compromise vision.
3. Store at ambient temperature.
4. DO NOT freeze or leave in sunlight.
5. Use only sterile balanced salt solution for rinsing or soaking of lens.
9. Patient Information: The patient identification card included in the package is to
be completed and given to the patient, together with instructions to keep this card as
a permanent record of the implant and to show the card to any eye care professional
seen in future.
10. Lens Power Calculation: The ideal refractive power of the lens should be determined
preoperatively. Both target position of the IOL and the experience of the surgeon should be
considered for the calculation. Depending on the axial length (AL), ZEISS recommends in
accordance with Hill [1] the following formulas:
Short eyes
AL < 22.0 mm
Normal eyes 22.0 mm < AL < 25.99 mm SRK / T
Long eyes
AL ≥ 26.0 mm
Please find the A-constants for the individual IOL types on the label of the cardboard box.
Please note that a thorough evaluation of the actual conditions in terms of diagnostics,
surgical instruments and the chosen algorithm for calculation is crucial for the expected
postoperative results. Only the use of individually optimized A-constants [3] can compensate
for the systematic deviations within the predictable range of postoperative refraction. The
following sources refer to methods for IOL power calculations:
[1] HILL, W. E. Choosing the right formula. http://www.doctor-hill.com/iol-main/formulas.
htm. Last visited on 2015-06-08
[2] SHAMMAS, H. J. Intraocular Lens Power Calculations. SLACK, Inc.
[3] HAIGIS, W. Optimized IOL Constants for the ZEISS IOLMaster calculated from patient data
on file. http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm. Last visited on 2015-06-08
11. Return / Exchange Policy: For return or exchange of product please contact the
manufacturer of your local distributor.
12. Limitation of warranty and liabillity: The implantation of an intraocular lens is
a surgical procedure and carries several risks associated with eye surgery. Carl Zeiss
Meditec AG has provided information and recommendations with respect to such risks as
well as methods and techniques of implantation of the lens. The doctor should provide
patients with all relevant information in this respect. In particular, Carl Zeiss Meditec AG
disclaims all liabilities in connection with injuries or damages that may be suffered by the
patient due to:
1. the method or technique of implantation used by the doctor if the recommendations
of Carl Zeiss Meditec AG have not been observed,
2. an unsuitable prescription selection or use of the intraocular lens for a particular patient
13. Symbols used on packaging
Sterilized using ethylene oxide
SN
Serial number
Do not reuse
Do not resterilize
Use by
Keep away from sunlight
Overall Diameter
Haigis (a0, a1, a2 optimized)
Holladay (ACD optimized)
, Haigis
[2]
Haigis (a0, a1, a2 optimized)
Store at ambient temperature.
,
[2]
, Hoffer Q
[2]
, Holladay
, Hoffer Q
[2]
[2]
,Holladay (SF optimized)
[2]
Consult instructions for use
Keep dry
Do not use if package is damaged
Date of manufacture
Manufacturer
Catalogue number
Optic Diameter
[2]
[2]
[2]
-3-
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