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DEVICE DETAILS

NAME OF DEVICETEK-LENS II THREE PIECE HYDROHILIC ACRYLIC INTRAOCULAR LENS
ESTABLISHMENT NAMETRANSMEDIC HEALTHCARE SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC8612022-84228
BRAND NAMETEKIA
MEDICAL DEVICE CATEGORYMD 0203 - Non-active functional implants
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONTEKIA 3 piece hydrophilic acrylic IOLs are foldable intraocular lenses(IOL’s) designed to be implanted in place of the natural lens after extracapsular cataract extraction. They consist of an hydrophilic acrylic optic lathed and milled from a HEMA/ MMA copolymer material containing a UV blocker and which foldability is obtained through hydration. The yellow ( Y) IOLs series are manufactured from the same hydrophilic acrylic material which incudes additionally a blue light blocker.
DEVICE INTENDED PURPOSETEKIA 3 piece hydrophilic acrylic IOLs are designed to be implanted in the posterior chamber of the eye after the extraction of cataract in the following conditions: senile cataract, traumatic cataract, congenital cataract.
VALIDITY DATE OF REGISTRATION24/01/2022 - 23/01/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Tek-Lens™ II Three Piece Hydrophilic Acrylic Intraocular Lenses617
2Tek-Lens™ II Three Piece Hydrophilic Acrylic Intraocular Lenses617Y
3Tek-Lens™ II Three Piece Hydrophilic Acrylic Intraocular Lenses618
4Tek-Lens™ II Three Piece Hydrophilic Acrylic Intraocular Lenses618Y
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