A PROJECT

ON “QUALITY CHECK CONTROL”IN

IOL’S

By

GANESH.N
&
LAKSHMIKANTH.N

SRM SCHOOL OF MANAGMENT

Submitted to the

FACULTY OF MANAGEMENT STUDIES

In partial fulfillment of the requirements
for the award of the degree
of
MASTER OF BUSINESS ADMINISTRATION
SRM UNIVERSITY
JUNE &JULY – 2010

SRM UNIVERSITY
DEPARTMENT OF MANAGEMENT STUDIES
SRM Nagar, Kattankulathur - 603203, Kancheepuram District, Tamil Nadu.
Phone: +91-44-2745 2270 extn: 7001 Fax: +91-44-2745 2343
 E-Mail: registrar@srmuniv.ac.in

BONAFIDE CERTIFICATE

Certified that this report titled “A Study on Buying Decision Process” is a bonafide work of
Mr. GANESH.N,& LAKSHMIKANTH.N Register No: 3510910211who carried out the
work under my supervision. Certified further that to the best of my knowledge the work
reported here in does not form part of any other project report on the basis of which a degree
or award was conferred on an earlier occasion on this or any other candidate.

Mr.SENTHIL KUMAR Dr.Mrs.

JAYSHREE
(Faculty In charge) (DEAN-MBA)

Viva Voce Conducted

Internal Examiner:
External Examiner:

ACKNOWLEDGEMENT

We express our gratitude to Dr. Jayshree Suresh, Dean, SRM School of

Management, SRM University, for providing an amazing environment for us to complete
this project successfully.
 We thank Mr.SENDHIL KUMAR, Assistant Professor, Department of business
Administration for her constant encouragement and valuable guidance throughout the
tenure of the project.
 CONTENT

CHAPTER NO TOPIC PAGE NO

CHAPTER 1 INTRODCTION 07

1.1 Company Profile 07

1.2 Objectives 12

CHAPTER 2 RESEARCH METHODOLOGY

2.1 Data collection 13

Tools for data analysis 17

Simple percentage analysis 18

CHAPTER 3 DATA ANALYSIS AND INTERPRETATION 19

CHAPTER 4 SUGGESTION AND RECOMMENDATION 20

CHAPTER 5 CONCLUSION 21

ANNEXURE

CHAPTER NO.1
INTRODUCTION

Since 1978, Appasamy Associates and Group of companies have been leading
manufacturers and distributors of ophthalmic equipment, microscopes, lasers, IOLs,
microsurgical instruments and pharmaceuticals. Our three decades of work have been widely
appreciated throughout the world. Our dedication to support our products had become a
bench mark among the community. We have dedicated R & D team to fulfill state of the art
requirements of the ophthalmic community. More than 15% expenses are spend on
development of new products. We strive hard to make each and every modern technology and
equipment within the easy reach of ophthalmic surgeons and visions care professionals in
India. Our various manufacturing facilities at Chennai and Pondicherry have got quality
systems certifications, audited by TUV, DNV and ITC for ISO 9000 and ISO 13485
requirements. The certifications bodies also provided CE marking for various products and
CE compliance certifications for Class I products. Our Slit Lamps and Keratometer had been
awarded UL mark. We dedicate and resolve ourselves to continue our work, which will
engulf the common man with easier and affordable access to the best possible vision care
services.

ALLIANCE PARTNER
Exclusive Distributor in India for

Auto Refractometer, Autoref Keratometer,

Canon Inc, Medical Equipment Division,
Japan
DGH Technology Inc., USA
Fundus Camera, and Automated Non-Contact
Tonometer
Ultra Sound Scanning Equipment - A Scan
and Pachymeter
Intra Ocular Lenses, Ultrasonic A - Scan

ELLIS Ophthalmic Technologies Inc., USA

Authorised Distributor in India for
Auto Refractometer, Autoref Keratometer and
Automatic Lensmeter and Trial
Lens Frames
Grand Seiko Co. Ltd., Japan
All Ophthalmic Equipment & Instruments

Inami & CO., Ltd., Japan

Ophthalmoscope, Retinoscope and Schiotz
Rudolf Riester GMBH., Germany Tonometers
Diagnostic, Imaging and Laser Delivery
Volk Optical, Ohio, USA Lenses.
Autoref Keratometer
Potec Co.Ltd., Korea

Authorised Distributor in USA

Venkat Ravilla
745, Rande Lane
Hoffman Estates, IL 60194
Phone:(847) 885-7655
 AWARDS

Best Woman Entrepreneur of the year award, instituted by Government of

Tamilnadu for the year 1993. (First awardee in this category since its inception)
One of the Best 5 Women Entrepreneurs of the year 1994, instituted by National
Alliance of Young Entrepreneurs.
Engineering Export Promotion Council (EEPC) of India award for the best
performance under the category Small Scale Industries - Certificate of merit for
1993-1994 among Southern Region of EEPC of India.

STRENGTH

WE OFFER THE BEST AFTER SALES SERVICE

We are committed to our customers and we draw strength from their faith on our ability to
help them better than others.

We train our sales and service persons to help our customers in best possible ways and means
and methods.

We regularly reinvest our profits to upgrade our manufacturing facilities. We regularly

upgrade our products and the benefits are always passed to the old customers with nominal
cost.

We regularly introduce new products and always in search of people who can develop new
products. If you have a new product to offer, you are welcome to contact us

We offer products at a reasonable price, at best quality, always reliable performance and with
effective after sales service support. Our employees are given opportunity to prove
themselves. Selected persons are sent abroad for sales, service and training. We trust them
and rely on their abilities to serve our customers to the best possible extent.

We are proud of our products, our employees and our customer's faith on us and support
given by them.

MILESTONE

1978 Introduced India's first low cost cryo surgical equipment for ophthalmology. Indian
prices Rs.1800, whereas an equivalent imported unit costs Rs.20,000. Import of cryo surgical
equipment in ophthalmology virtually had stopped fifteen years ago.

1979 Introduced world's first non-electric Vitrectomy unit in ophthalmology (another import
substitute).This product is one of the most reliable one and virtually trouble free unit. We
know many eminent surgeons use this Rs.18,000 unit instead of their imported unit.

Priced imported units (as high as Rs.500,000). Import of Vitrectomy units has been reduced
to minimum and virtually no one imports vitrectomy units since 1985. We also manufacture
and sell electrical vitrectomy units with peristaltic pump for aspiration with linear suction.

1980 Started manufacturing and selling Keratometer. Our Keratometer AAK6 is an OEM
supply, Market share in India is more than 95%.

1987 Started manufacturing Surgical Operating Microscopes. Since then, AAOM 10 is the
largest selling Operating Microscope in India. We introduced our own optical head with five-
step magnification, with facility for videography and photography in 1998. We also
manufacture and sell microscopes for ENT, O&G and Plastic Surgery.

1989 Started manufacturing and selling Slit Lamps. Photography and Videography models
are also made available.

1989 Started manufacturing multi piece Intra Ocular Lenses. The entire plant and machinery
designed, fabricated and manufactured in India with our own know-how technology.

Started selling IOLs in 1992.

Started manufacturing and selling single piece IOLs in 1995.

On December 31, 1997 we completed ISO 9002 audit for Intra Ocular Lenses. AI Optics
Limited, our INTRA OCULAR LENS manufacturing unit becomes an ISO 9002(Quality
Systems and Requirements fulfilled) facility and certified by TUV, Germany on 17.03.1998.

1990 Started manufacturing and selling Indirect Ophthalmoscope.

1994 Introduced India's first Ophthalmic Nd.YAG Laser equipment. It is only one of its kind
manufactured in India till today. Also started manufacturing and selling Streak Retinoscope.

1995 Introduced India's first Phaco Emulsification Equipment for small incision sutureless
surgery.

OBJECTIVE:
To do the quality check on IOL’s by using statistical tools.

INTRODUCTION:

An intraocular lens (IOL) is an implanted lens in the eye, usually

replacing the existing crystalline lens because it has been clouded over by a cataract, or as a
form of refractive surgery to change the eye's optical power. It usually consists of a small
plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular
bag inside the eye.IOLs were traditionally made of an inflexible material (PMMA), although
this has largely been superseded by the use of flexible materials. Most IOLs fitted today are
fixed monofocal lenses matched to distance vision. However, other types are available, such
as multifocal IOLs which provide the patient with multiple-focused vision at far and reading
distance, and adaptive IOLs which provide the patient with limited visual accommodation.

Insertion of an intraocular lens for the treatment of cataracts is the

most commonly performed eye surgical procedure] The procedure can be done under local
anesthesia with the patient awake throughout the operation. The use of a flexible IOL enables
the lens to be rolled for insertion into the capsule through a very small incision, thus avoiding
the need for stitches, and this procedure usually takes less than 30 minutes in the hands of an
experienced ophthalmologist. The recovery period is about 2–3 weeks. After surgery, patients
should avoid strenuous exercise or anything else that significantly increases blood pressure.
They should also visit their ophthalmologists regularly for several months so as to monitor
the implants. IOL implantation carries several risks associated with eye
surgeries, such as infection, loosening of the lens, lens rotation, inflammation, night time
halos. Though IOLs enable many patients to have reduced dependence on glasses, most
patients still rely on glasses for certain activities, such as reading.

Materials used for intraocular lenses

Polymethylmethacrylate (PMMA) was the first material to be used successfully in intraocular

lenses. British ophthalmologist Sir Harold Ridley observed that Royal Air Force pilots who
sustained eye injuries during World War II involving PMMA windshield material did not
show any rejection or foreign body reaction. Deducing that the transparent material was inert
and useful for implantation in the eye, Ridley designed and implanted the first intraocular
lens in a human eye.

Advances in technology have brought about the use of silicone and acrylic, both of which are
soft foldable inert materials. This allows the lens to be folded and inserted into the eye
through a smaller incision. PMMA and acrylic lenses can also be used with small incisions
and are a better choice in people who have a history of uveitis, have diabetic retinopathy
requiring vitrectomy with replacement by silicone oil or are at high risk of retinal
detachment. Acrylic is not always an ideal choice due to its added expense. New FDA-
approved multifocal intraocular lens implants allow most post operative cataract patients the
advantage of glass-free vision. These new multifocal lenses are not a covered expense under
most insurance plans (In the United States, Medicare decided to stop covering them in May
2005) and can cost the patient upwards of $2800 per eye. Latest advances include IOLs with
square-edge design, non-glare edge design and yellow dye added to the IOL.

In the United States, a new category of intraocular lenses was opened with the approval by
the Food and Drug Administration in 2003 of multifocal and accommodating lenses. These
come at an additional cost to the recipient beyond what Medicare will pay and each has
advantages and disadvantages.

Multifocal IOLs - provide for simultaneous viewing of both distance vision and near vision.
Some patients report glare and halos at night time with these lenses.

Accommodating IOLs - allow for both distance vision and midrange near vision. These IOLs
are typically not as strong for closer vision as the multifocal IOLs.

To incorporate the strengths of each type of IOL, eye surgeons are increasing using a
multifocal IOL in one eye to emphasize close reading vision and an accommodating IOL in
the other eye for further midrange vision. This is called "mix and match." Distance vision is
not compromised with this approach, while near vision is optimized.

Other IOLs include:

• Blue Light Filtering IOLs filter the UV and high-energy blue light present in natural
and artificial light, both of which can cause vision problems.
• Toric IOLs (1998) correct astigmatic vision.

Intraocular lenses for correcting refractive errors

Intraocular lenses have been used since 1999 for correcting larger errors in myopic (near-
sighted), hyperopic (far-sighted), and astigmatic eyes. This type of IOL is also called PIOL
(phakic intraocular lens), and the crystalline lens is not removed.

More commonly, aphakic IOLs (that is, not PIOLs) are implanted via Clear Lens Extraction
and Replacement (CLEAR) surgery. During CLEAR, the crystalline lens is extracted and an
IOL replaces it in a process that is very similar to cataract surgery: both involve lens
replacement, local anesthesia, both last approximately 30 minutes, and both require making a
small incision in the eye for lens insertion. People recover from CLEAR surgery 1–7 days
after the operation. During this time, they should avoid strenuous exercise or anything else
that significantly raises blood pressure. They should also visit their ophthalmologists
regularly for several months so as to monitor the IOL implants. CLEAR has a 90% success
rate (risks include wound leakage, infection, inflammation, and astigmatism). CLEAR can
only be performed on patients ages 40 and older. This is to ensure that eye growth, which
disrupts IOL lenses, will not occur post-surgery.

Once implanted, IOL lenses have three major benefits. First, they are an alternative to
LASIK, a form of eye surgery that does not work for people with serious vision problems.
Effective IOL implants also entirely eliminate the need for glasses or contact lenses post-
surgery for most patientsThe cataract will not return, as the lens has been removed. The
disadvantage is that the eye's ability to change focus (accommodate) has generally been
reduced or eliminated, depending on the kind of lens implanted.

Most PIOLs have not yet been approved by FDA, but many are under investigation, and
some of the risks that FDA have been found so far during a three year study of the Artisan
lens, produced by Ophtec USA Inc, are:

• a yearly loss of 1.8% of the endothelial cells,

• 0.6% risk of retinal detachment,
• 0.6% risk of cataract (other studies have shown a risk of 0.5 - 1.0%), and
• 0.4% risk of corneal swelling.

Other risks include:

• 0.03 - 0.05% eye infection risk, which in worst case can lead to blindness. This risk
exists in all eye surgery procedures, and is not unique for IOLs.
• glaucoma,
• astigmatism,
• remaining near or far sightedness,
• rotation of the lens inside the eye within one or two days after surgery.

Types of PIOLs

Phakic IOLS (PIOLs) can be either spheric or toric—the latter is used for astigmatic eyes.
The difference is that toric PIOLs have to be inserted in a specific angle, or the astigmatism
will not be fully corrected, or it can even get worse.

According to placement site in the eyes phakic IOLs can be divided to:

Angle supported PIOLs: those IOLs are placed in the anterior chamber. They are notorious
for their negative impact on the corneal endothelial lining, which is vital for maintaining a
healthy dry cornea.

• Iris supported PIOLs: this type is gaining more and more popularity. The IOL is
attached by claws to the mid peripheral iris by a technique called enclavation. It is
believed to have a lesser effect on corneal endothelium.

• Sulcus supported PIOLs: these IOLS are placed in the posterior chamber in front of
the natural crystalline lens. They have special vaulting so as not to be in contact with
the normal lens. The main complications with this type is their tendency to cause
cataracts and/or pigment dispersion.

Accommodating IOLs

One of the major disadvantages of conventional IOLs is that they are primarily focused for
distance vision. Though patients who undergo a standard IOL implantation no longer
experience clouding from cataracts, they are unable to accommodate, or change focus from
near to far, far to near, and to distances in between. Accommodating IOLs interact with
ciliary muscles and zonules, using hinges at both ends to “latch on” and move forward and
backward inside the eye using the same mechanism as normal accommodation. These IOLs
have a 4.5-mm square-edged optic and a long hinged plate design with polyimide loops at the
end of the haptics. The hinges are made of an advanced silicone called BioSil that was
thoroughly tested to make sure it was capable of unlimited flexing in the eye. There are
many advantages to accommodating IOLs. For instance, light comes from and is focused on a
single focal point, reducing halos, glares, and other visual aberrations. Accommodating IOLs
provide excellent vision at all distances (far, intermediate, and near), project no unwanted
retinal images, and produce no loss of contrast sensitivity or central system adaptation.
Accommodating IOLs have the potential to eliminate or reduce the dependence on glasses
after cataract surgery. For some, accommodating IOLs may be a better alternative to
refractive lens exchange (RLE) and monovision.

The FDA approved Eyeonics Inc.’s accommodating IOL, Crystalens AT-45, in November
2003. Bausch & Lomb acquired Crystalens in 2008 and introduced a newer model called
Crystalens HD in 2008. Crystalens is the only FDA-approved accommodating IOL currently
on the market[3] and it is approved in the United States and Europe.

CHAPTER NO.2
RESEARCH METHODOLOGY

2.1 DATA COLLECTION:

Data’s which are used on this project is collected myself using the instrument
RADIO SCOPE.

1.2 TOOLS USED FOR ANALYSIS DATA:

P-Chart and Q-Chart are tools used for this project.
 CHAPTER NO.3
DATA ANALYSIS AND INTERPRETATION

These shows that all the lenses manufactured are in right quality and it is proved by statistical
tool.

CHAPTER NO.5
CONCLUSION

From this project I have learnt how to manufacture the lens and to check its quality.