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About Defects In Intraocular
Lens ( IOL )
Intraocular lens may have defect
during the manufacturing process and implantation into the
patients' eyes. This ranges from the production of IOL, packaging,
distribution, insertion to when the IOL is already implanted into
the patients' eyes.
Defect may range from manufacturing
defect such as no IOL in the box or fracture of haptics or optics.
It may also be in the form of deposits on the IOL or opacification
detected weeks to years after surgery. All these defects will
contribute directly to the patients' visual outcome. Some defects
may require explantation and results in distress to both the
patients and surgeons. Cost for explantation of an opacified IOL
also has to be borne by the patient and eye care providers.
It is also important to identify any
common defect for example fracture of haptics or optics as this
will be used as feedback to the industries to improve their IOL
quality or be used for platform for further training pertaining to
the IOL if required.
CDSCO Medical Device alert on IOLs
CDSCO has issued a medical device
alert on certain batches of Hoya Vivinex Toric IntraOcular Lens (IOLs)
manufactured from June, 2022 to January, 2023. The Company has
started recalling these IOLs under recall action classification
Class II, because of reports of damage (such as scratches) and
fragment adhesion on the IOL optic surface.
Hoya identified that damage had
occurred to the nozzle tip of the iSert injector during Toric IOL
implantation. This damage might have led to the reported scratches
on the optic surface and polypropylene (PP) resin fragments from
inside the injector tip to adhere to the IOL surface (PP
adhesion)” Hoya is a global med-tech company founded in 1941 in
Tokyo, Japan and it is a leading supplier of innovative high-tech
and medical products.The company has its Indian arm as Hoya
Medical India Pvt Ltd, in New Delhi. The Company has recommended
that the patients involved, that is the cases where lenses with PP
adhesion have been left in the eye, be monitored for the need for
any future medical treatment.
As per Hoya, lenses are made from a
novel hydrophobic acrylic, using a proprietary manufacturing
process that includes a unique, active oxygen posterior surface
treatment. Combined with its square edge design and smooth,
regular IOL surface, it has been demonstrated to provide a low
incidence of Posterior Capsule Opacification (PCO) in several
studies.
(
https://www.acrm.org.my/ned/adverseIncident.html ) ,
http://www.pharmabiz.com/NewsDetails.aspx?aid=158376&sid=1
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