AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX
FDA device recall Z-2310-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- VISX INCORPORATED, A SUBSIDIARY OF AMO INC
- Reason for recall
- Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.
- Action taken
- 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
- Status
- Terminated
- Product code
- LZS
- Quantity affected
- 160 kits
- Distribution
- Product was distributed to 152 customers throughout the United States.
- Date initiated
- 2008-06-09
- Date posted
- 2008-09-17
- Date terminated
- 2011-02-15
- Location
- Santa Clara, CA
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