Beaver Visitec International, Inc. - Class 2 Recall
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2021 Category: Medical Devices Source Type: alerts
Beaver Visitec International, Inc. - Malosa Core LASIK Pack - Class 2 Recall
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2021 Category: Medical Devices Source Type: alerts
ROi CPS LLC - Basic Cataract tray - Class 2 Recall
REGARD Basic Cataract tray (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2021 Category: Medical Devices Source Type: alerts
Beaver Visitec International, Inc. - Class 2 Recall
bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2021 Category: Medical Devices Source Type: alerts
Beaver Visitec International, Inc. - Class 2 Recall
bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2021 Category: Medical Devices Source Type: alerts
Beaver Visitec International, Inc. - Class 2 Recall
bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2021 Category: Medical Devices Source Type: alerts
Beaver Visitec International, Inc. - BVI Beaver Xstar Crescent Knife - Class 2 Recall
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2021 Category: Medical Devices Source Type: alerts
Johnson & Johnson Surgical Vision Inc - TECNIS EyhanceTM Toric II IOLs with TECNIS Simplicity Delivery System/Model Number DIU225U050) - Class 2 Recall
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
ROi CPS LLC - Regard - Class 2 Recall
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO,...
Source: Medical Device Recalls - December 29, 2020 Category: Medical Devices Source Type: alerts
Beaver Visitec - Beaver Xstar Slit Knife - Class 2 Recall
Beaver¿ Xstar Slit Knife 2.4 mm, 45¿ Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 2019 Category: Medical Devices Source Type: alerts
Alcon Research Laboratories Ltd. - Alcon or Endure Ophthalmic Microscope (LuxOR E71 and LuxOR E71 QVue) - Class 2 Recall
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2019 Category: Medical Devices Source Type: alerts
Johnson & Johnson Surgical Vision Inc - Abbott TECNIS iTEC Preloaded Delivery System - Class 2 Recall
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts
Johnson & Johnson Surgical Vision Inc - OptiMedca Catalys Precision Laser System - Class 2 Recall
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery ...
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
SIE AG, Surgical Instrument Engineering - The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser - Class 2 Recall
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the cr...
Source: Medical Device Recalls - March 30, 2018 Category: Medical Devices Source Type: alerts
Oculus Optikgeraete GMBH - Pentacam AXL - Class 2 Recall
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cort...
Source: Medical Device Recalls - February 17, 2018 Category: Medical Devices Source Type: alerts
