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Manufacturers
Designs for Vision Aust Pty Ltd
Manufacturer Parent Company (2017)
Paragon Care Ltd.
Source
DHTGA
3 Events
Recall of Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13
Recall of Torix Disposable Toric IOL Marking and Alignment System
Recall of HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)
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3 devices in the database
Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13
Model / Serial
Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13Serial Numbers: 0031 7130, 2721 6111, 3821 7110ARTG Number: 175820 (Designs for Vision Aust Pty Ltd - Corneal topography system)
Torix Disposable Toric IOL Marking and Alignment System
Model / Serial
Torix Disposable Toric IOL Marking and Alignment SystemProduct codes: HYX-FG-02510 (10 sets sterilised)HYX-M-02512 (single pack)HYX-M-02530 (Intra-operative Axis Guide)HYX-M-02515 (Pre-operative Marker & Handle)Lot number: W06710ARTG Number: 200725
HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311),...
Model / Serial
HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)Affected Serial numbers ranges:KULX0011 - KUMZ0TN2)JKLX0012 - JKN10CE4JLLX0012 - JLN116T6PNLX0012 - PNMZ04Q8PPLX0011 - PPMZ01C8PQLX0021 - PQMZ00E7PRLX0011 - PRMZ00R6PSLX0012 - PSMZ0078PTLX0011 - PTMZ0048PULX0011 - PUMZ00E8PALY0011 - PAM200S6PBLY0011 - PBM200C8PCLY0011 - PCM200N8ARTG: 117417
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