FDA Medical Device Recalls (openFDA)
Visx Inc: Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
- Recall number
- Z-0365-2008
- Recalling firm
- Visx Inc
- Product
- Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
- Status
- Terminated
- Initiated
- 2007-05-30
- Posted
- 2008-01-23
- Terminated
- 2008-04-17
- Reason
- 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
- Root cause
- Software design
- Action
- 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).
- Quantity
- 196 systems are affected in the U.S. and 133 outside of the U.S.
- Distribution
- Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P930016/S26","P930016S016"]
- Product code
- LZS
- Firm FEI
- 1221842
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28