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.
- Recall Initiated
- June 9, 2008
- Posted
- September 17, 2008
- Terminated
- February 15, 2011
- Recall Number
- Z-2310-2008
- Quantity
- 160 kits
- Firm Location
- Santa Clara, CA
Reason for Recall
Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.
Distribution
Product was distributed to 152 customers throughout the United States.
Lot / Code Info
Serial Numbers: 10560 70250 70594 75133 12280 70252 70608 75137 14480 70259 70620 75172 70026 70260 70647 75183 70029 70261 70653 75192 70032 70267 70654 75198 70049 70268 70664 75233 70050 70271 70679 75241 70053 70274 70681 75248 70064 70278 70685 75263 70068 70279 70689 75267 70070 70328 70696 75276 70079 70334 70699 75278 70080 70354 70706 75280 70082 70362 70716 75297 70089 70366 70732 75301 70094 70376 70746 75305 70096 70386 70755 75354 70098 70391 70765 75401 70099 70406 70769 75412 70102 70421 70779 75445 70107 70425 70784 76014 70113 70427 70803 76062 70114 70429 70834 76080 70120 70451 70851 76105 70122 70453 70862 76117 70125 70456 70879 76118 70127 70475 70882 76190 70133 70495 70889 76195 70140 70496 70890 76216 70146 70497 75023 76217 70148 70501 75031 76223 70158 70504 75037 76233 70166 70506 75040 76259 70185 70512 75058 76273 70188 70537 75065 76274 70189 70539 75102 76356 70208 70548 75103 76384 70232 70549 75121 70241 70587 and 75126
Root Cause
Software design
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.