Abbott Medical Optics, Inc.

• HQC — Ophthalmic9 devices
• GEX — General, Plastic Surgery1 device
• LPN — Ophthalmic1 device
• MSS — Ophthalmic1 device
• OOE — Ophthalmic1 device

• Z-1515-2015 — OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.Class II·Terminated·2015-02-20
• Z-0047-2014 — 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.Class II·Terminated·2013-09-16
• Z-0049-2014 — 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.Class II·Terminated·2013-09-16
• Z-0048-2014 — 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.Class II·Terminated·2013-09-16
• Z-0046-2014 — 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.Class II·Terminated·2013-09-16
• Z-1541-2013 — 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.Class II·Terminated·2013-05-28
• Z-1540-2013 — 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.Class II·Terminated·2013-05-28
• Z-1539-2013 — 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.Class II·Terminated·2013-05-28
• Z-1670-2013 — Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.Class II·Terminated·2013-05-23

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K170322 — Catalys Precision Laser SystemCode OOE·2017-05-19
• K160236 — Dual Pump PackCode HQC·2016-04-27
• K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote ControlCode HQC·2015-10-19
• K151783 — COMPACT INTUITIV Multiple-Use PackCode HQC·2015-09-02
• K143434 — One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesCode MSS·2015-05-06
• K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACKCode HQC·2014-02-27
• K121721 — LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)Code HQC·2012-10-15
• K113151 — IFS LASER SYSTEMCode GEX·2012-03-08
• K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMCode HQC·2011-12-21
• K111882 — LAMINAR FLOW PHACO TIPSCode HQC·2011-11-07
• K111697 — AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEMCode HQC·2011-09-27
• K103023 — UNIT, PHACOFRAGMENTATIONCode HQC·2011-06-01
• K093254 — AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTIONCode LPN·2010-09-15