Abbott Medical Optics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1515-2015 | Class II | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). | February 20, 2015 |
| Z-0046-2014 | Class II | STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and di | September 16, 2013 |
| Z-0047-2014 | Class II | STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufact | September 16, 2013 |
| Z-0049-2014 | Class II | STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and | September 16, 2013 |
| Z-0048-2014 | Class II | STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Pr | September 16, 2013 |
| Z-1541-2013 | Class II | STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive M | May 28, 2013 |
| Z-1540-2013 | Class II | STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC | May 28, 2013 |
| Z-1539-2013 | Class II | STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood D | May 28, 2013 |
| Z-1670-2013 | Class II | Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for | May 23, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170322 | Catalys Precision Laser System | May 19, 2017 |
| K160236 | Dual Pump Pack | April 27, 2016 |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four | October 19, 2015 |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | September 2, 2015 |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | May 6, 2015 |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | February 27, 2014 |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | October 15, 2012 |
| K113151 | IFS LASER SYSTEM | March 8, 2012 |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | December 21, 2011 |
| K111882 | LAMINAR FLOW PHACO TIPS | November 7, 2011 |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | September 27, 2011 |
| K103023 | UNIT, PHACOFRAGMENTATION | June 1, 2011 |
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | September 15, 2010 |