STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas

FDA device recall Z-2971-2011 · posted 2011-08-09 · Terminated

Recall details

Recalling firm

AMO Manufacturing USA, LLC

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.

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.

Root cause

Software design

Status

Terminated

Product code

LZS

Quantity affected

673 total - v5.00 -5.22

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.

Date initiated

2011-07-18

Date posted

2011-08-09

Date terminated

2013-09-10

Location

Milpitas, CA