Nidek Inc - Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII. - Class 2 Recall
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2014 Category: Medical Equipment Source Type: alerts
Laser Peripherals LLC - DBLF602 Bare Laser fiber - Class 2 Recall
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 18, 2014 Category: Medical Equipment Source Type: alerts
Alcon LenSx, Inc. - Common Name: LenSx Laser System. - Class 2 Recall
Trade Name: LenSx Laser. Classification Name: Class II Ophthalmic Laser. The LenSx Laser System introduced in August 2011 is intended for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. The Patient Interface (PI) is inserted onto the delivery system for each new procedure and serves to hold the eye in the correct position for the laser procedure. During the set up phase of the procedure, the contact lens of the PI is docked onto the patient s eye by moving the gantry, which is controlled by a joystick. 510(K) Number: K123120 Device Listing Numb...
Source: Medical Device Recalls - April 10, 2014 Category: Medical Equipment Source Type: alerts
Carl Zeiss Meditec AG - VisuMax Laser Keratome - Class 2 Recall
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 2014 Category: Medical Equipment Source Type: alerts
Ziemer Usa Inc - 1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6 - Class 2 Recall
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a var...
Source: Medical Device Recalls - January 24, 2014 Category: Medical Equipment Source Type: alerts
Optimedica Corporation - OptiMedica Catalys - Class 2 Recall
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 9, 2014 Category: Medical Equipment Source Type: alerts
Convergent Dental - Solea 1.0 - Class 2 Recall
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR ActiveTrak Excimer Laser System - Class 2 Recall
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR Excimer Laser - Class 2 Recall
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR IR Excimer Laser - Class 2 Recall
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR Excimer Laser System with Variable Spot Scanning - Class 2 Recall
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2013 Category: Medical Equipment Source Type: alerts
PhotoMedex, Inc. - Surgical Laser Technologies, Inc. (SLT) SSRH - Class 2 Recall
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Produc...
Source: Medical Device Recalls - October 2, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR S3 ActiveTrack Excimer System (STAR S3) - Class 2 Recall
STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 14, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR S4 with Variable Spot Scanning Excimer System (STAR S4) - Class 2 Recall
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 14, 2013 Category: Medical Equipment Source Type: alerts
Abbott Medical Optics, Inc. - STAR S4 IR Excimer System (STAR S4 IR) - Class 2 Recall
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 14, 2013 Category: Medical Equipment Source Type: alerts
