AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors of the eye.
FDA Recall Z-2310-2008 · Posted 2008-09-17
Advertisement
Recalling FirmVISX INCORPORATED, A SUBSIDIARY OF AMO INC
Recall StatusTerminated
Product CodeLZS
Date Initiated2008-06-09
Date Terminated2011-02-15
Product Quantity160 kits
Reason for Recall
Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.
Firm Action
A product advisory notice was mailed to all consignees on June 9, 2008, advising consignees to closely monitor the WaveScan results to ensure that mistreatment is not given to patients. The firm has ceased distributing the updated software. ***UPDATE 08/29/2008*** The firm revised its recall strategy on 08/28/2008 because the firm was informed that a 180 day PMA supplement rather than a real time review supplement would be required for the software upgrade approval. The firm will instead revert products to the previous software version, 3.67/3.671.
If you have questions, contact 1-877-AMO-4LIFE, options 1, 2, and then 2.
Root Cause
Software design
Distribution Pattern
Product was distributed to 152 customers throughout the United States.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement