Recall Z-2310-2008 ยท LZS Excimer Laser System
VISX INCORPORATED, A SUBSIDIARY OF AMO INC
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
| Date | Sep 17, 2008 (initiated Jun 9, 2008) |
| Status | Terminated |
| Reason | Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight. |
| Root cause | Software design |
| 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- |
| Quantity | 160 kits |
| Distribution | Product was distributed to 152 customers throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.