Visx Inc Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
Brand
Visx Inc
Lot Codes / Batch Numbers
System Serial Numbers affected include: 75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391, 75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091, 76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111, 76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123, 76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033, 76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146, 76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032, 76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431, 75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126, 76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021, 76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163, 70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890, 75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037, 76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150, 76151, 76153, 76155, 76156, 76157, 76159, 76160, 76162, 70272, 70280, 70297, 70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397, 75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439, 76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734, 76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864, 75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406, 75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005, 75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178, 76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060, 70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107, 70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440, 76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580, 70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072, 76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241, 70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and 76041
Products Sold
System Serial Numbers affected include: 75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391, 75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091, 76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111, 76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123, 76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033, 76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146, 76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032, 76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431, 75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126, 76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021, 76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163, 70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890, 75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037, 76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150, 76151, 76153, 76155, 76156, 76157, 76159, 76160,76162, 70272, 70280, 70297, 70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397, 75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439, 76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734, 76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864, 75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406, 75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005, 75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178, 76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060, 70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107, 70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440, 76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580, 70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072, 76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241, 70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and 76041
Visx Inc is recalling Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Adv due to Erroneous Treatment Calculations - Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Erroneous Treatment Calculations - Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the "off
Recommended Action
Per FDA guidance
AMO sent an Action Required notification on May 30, 2007, to AMO Certified Physicians. The letter included a CD software update (0070-1721) to be installed by users that provided correct registry parameter settings. Upon completion of installation, a confirmation form will print out. Customers are requested to fax back confirmation to AMO (408-773-7055).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI
Page updated: Jan 10, 2026