STAR S4 IR Excimer Laser System; Software Version 5.01 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.
- Company
- Amo Manufacturing Usa, Llc
- Recall Initiated
- July 18, 2011
- Posted
- August 9, 2011
- Terminated
- September 10, 2013
- Recall Number
- Z-2966-2011
- Quantity
- 673 total - v5.00 -5.22
- Firm Location
- Milpitas, CA
Reason for Recall
Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version.
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
Lot / Code Info
Model # 0030-4577
Root Cause
Software design
Action Taken
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number. Contact an AMO representative for questions regarding this notice.