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Sources: EU EUDAMED, US FDA
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Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
FDA Recall
Open, Classified
·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code MTA·April 20, 2026
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
FDA Recall
Terminated
·Tecan US, Inc.·Product code NHG·January 12, 2018
FreshLook Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL -0.75, AXIS 020, LOT ***, 2006-04, WJ, Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plaines, IL 60018 USA, Made in USA. Product is packed in 6 packs.
FDA Recall
Terminated
·Ciba Vision Corporation·Product code LPM·March 11, 2004
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code MJP·January 27, 2021
Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
FDA Recall
Terminated
·Vistakon·Product code LPM·July 16, 2010
Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-58 P, Desc CYL 02 ALUM 400 LITER, Catalog #31-10-2014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product 0022-96, Desc CYL 02 ASSY., 637.2 LITER, Catalog #31-10-0017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty Jumbo D aluminum oxygen cylinders, 72 cylinders per skid labeled as: Product #0022-96D, Desc: CYL 02, JUMBO D, A VLV, 72/SKID, Catalog #31-10-0117. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023