Exact FDA event identifier

Event 96594

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 27, 2025
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Bausch & Lomb Surgical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

Z-1679-2025

Recall number: Z-1679-2025
Initiated: March 27, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Bausch & Lomb Surgical, Inc.
Quantity: 236,840

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

Code information

Description/Lots/UDI-DI: enVista Monofocal IOL (EEU)/3Q25120, 3Q25326, 3Q25327, 3Q25347, 3Q25348, 3Q25425, 3Q25426, 3Q25427, 3Q25507, 3Q25508, 3Q25509, 3Q25510, 3Q25511, 3Q25548, 3Q25549, 3Q25550, 3Q25628, 3Q25632, 3Q25730, 3Q25731, 3Q25840, 3Q25843, 3Q25934, 3Q25935, 3Q25936, 3Q25937, 3Q25938, 3Q25939, 3Q25940, 3Q25941, 3Q25942, 3Q25943, 3Q25944, 3Q26009, 3Q26010, 3Q26041, 3Q26042, 3Q26043, 3Q26044, 3Q26069, 3Q26070, 3Q26071, 3Q26072, 3Q26119, 3Q26120, 3Q26121, 3Q26122, 3Q26123, 3Q26202, 3Q26203, 3Q26204, 3Q26220, 3Q26255, 3Q26262, 3Q26301, 3Q26305, 3Q26306, 3Q26328, 3Q26329, 3Q26330, 3Q26331, 3Q26332, 3Q26333, 3Q26334, 3Q26348, 3Q26422, 3Q26424, 3Q26425, 3Q26444, 3Q26445, 3Q26446, 3Q26520, 3Q26521, 3Q26522, 3Q26614, 3Q26617, 3Q26618, 3Q26681, 3Q26682, 3Q26683, 3Q26684, 3Q26733, 3Q26734, 3Q26735, 3Q26747, 3Q26801, 3Q26802, 3Q26833, 3Q26834, 3Q26835, 3Q26836, 3Q26911, 3Q26912, 3Q26913, 3Q26914, 3Q26916, 3Q27101, 3Q27102, 3Q27103, 3Q27104, 3Q27201, 3Q27202, 3Q27203, 3Q27226, 3Q27253, 3Q27254, 3Q27255, 3Q27336, 3Q27337, 3Q27450, 3Q27451, 3Q27452, 3Q27453, 3Q27454, 3Q27455, 3Q27520, 3Q27620, 3Q27808, 3Q27809, 3Q27928, 3Q27929, 3Q27930, 3Q28021, 3Q28022, 3Q28101, 3Q28137, 3Q28138, 3Q28139, 3Q28712, 3Q28713, 3Q28714, 3Q28812, 3Q28813, 3Q28815, 3Q28816, 3Q28913, 3Q28914, 3Q28915, 3Q29033, 3Q29034, 3Q29140, 3Q29141, 3Q29142, 3Q29215, 3Q29216, 3Q29217, 3Q29218, 3Q29255, 3Q29319, 3Q29320, 3Q29422, 3Q29423, 3Q29424, 3Q29425, 3Q29524, 3Q29526, 3Q29537, 3Q29646, 3Q29647, 3Q29648, 3Q29649, 3Q29723, 3Q29724, 3Q29725, 3Q29726, 3Q29727, 3Q29817, 3Q29818, 3Q29904, 3Q29905, 3Q29924, 3Q30032, 3Q30033, 3Q30034, 3Q30141, 3Q30142, 3Q30143, 3Q30144, 3Q30145, 3Q30215, 3Q30250, 3Q30253, 3Q30325, 3Q30326, 3Q30442, 3Q30443, 3Q30444, 3Q30525, 3Q30526, 3Q30527, 3Q30528, 3Q30529, 3Q30602, 3Q30638, 3Q30639, 3Q30640, 3Q30641, 3Q30644, 3Q30645, 3Q30833, 3Q30834, 3Q30835, 3Q30836, 3Q30928, 3Q30929, 3Q30930, 3Q30948, 3Q30949, 3Q31005, 3Q31044, 3Q31045, 3Q31136, 3Q31138, 3Q31140, 3Q31233, 3Q31234, 3Q31240, 3Q31301, 3Q31302, 3Q31303, 3Q31364, 3Q31404, 3Q31405, 3Q31452, 3Q31547, 3Q31548, 3Q31550, 3Q31557, 3Q31558, 3Q31559, 3Q31625, 3Q31626, 3Q31627, 3Q31628, 3Q31744, 3Q31745, 3Q31807, 3Q31808, 3Q31934, 3Q31935, 3Q31936, 3Q31937, 3Q32028, 3Q32029, 3Q32036, 3Q32134, 3Q32135, 3Q32136, 3Q32252, 3Q32254, 3Q32305, 3Q32306, 3Q32346, 3Q32445, 3Q32446, 3Q32453, 3Q32454, 3Q32509, 3Q32510, 3Q32511, 3Q32604, 3Q32746, 3Q32747, 3Q32748, 3Q32749, 3Q32750, 3Q32751, 3Q32752, 3Q32753, 3Q32802, 3Q32803, 3Q32804, 3Q32805, 3Q32806, 3Q32906, 3Q32907, 3Q32951, 3Q33005, 3Q33007, 3Q33056, 3Q33125, 3Q33126, 3Q33127, 3Q33201, 3Q33202, 3Q33209, 3Q33525, 3Q33526, 3Q33564, 3Q33565, 3Q33617, 3Q33618, 3Q33619, 3Q33620, 3Q33622, 3Q33623, 3Q33830, 3Q33831, 3Q33832, 3Q33833, 3Q33834, 3Q33835, 3Q33837, 3Q33930, 3Q33931, 3Q33932, 3Q33933, 3Q33934, 3Q33936, 3Q34128, 3Q34130, 3Q34131, 3Q34132, 3Q34134, 3Q34240, 3Q34241, 3Q34242, 3Q34244, 3Q34245, 3Q34337, 3Q34338, 3Q34339, 3Q34340, 3Q34341, 3Q34342, 3Q34420, 3Q34421, 3Q34422, 3Q34441, 3Q34508, 3Q34509, 3Q34510, 3Q34511, 3Q34512, 3Q34639, 3Q34641, 3Q34733, 3Q34736, 3Q34804, 3Q34823, 3Q34909, 3Q34910, 3Q35033, 3Q35034, 3Q35110, 3Q35112, 3Q35202, 3Q35206, 3Q35416, 3Q35417, 3Q35614, 3Q35637, 3Q35702, 3Q35756, 3Q35810, 3Q35902, 3R00215, 3R00317, 3R00320, 3R00403, 3R00430, 3R00432, 3R00434, 3R00640, 3R00642, 3R00643, 3R00645, 3R00840, 3R00920, 3R00921, 3R01131, 3R01338, 3R01509, 3R01930, 3R01931, 3R02233, 3Q25121, 3Q25328, 3Q25346, 3Q25841, 3Q26040, 3Q26347, 3Q26615, 3Q26616, 3Q28814, 3Q29032, 3Q30035, 3Q30248, 3Q30258, 3Q31137, 3Q31549, 3Q32253, 3Q32905, 3Q33124, 3Q34129, 3Q34803, 3Q35613, 3R00922, 3R01513, 3R02827/ 10757770635921, 10757770607492, 10757770607515, 10757770607539, 10757770607553, 10757770607577, 10757770607591, 10757770607614, 10757770607638, 10757770607652, 10757770607676, 10757770607683, 10757770607690, 10757770607706, 10757770607713, 10757770607720, 10757770607737, 10757770607744, 10757770607751, 10757770607768, 10757770607775, 10757770607782, 10757770607799, 10757770607805, 10757770607812, 10757770607829, 10757770607836, 10757770607843, 10757770607850, 10757770607867, 10757770607874, 10757770673930, 10757770607898, 10757770607904, 10757770607911, 10757770607928, 10757770607935, 10757770607942, 10757770607959, 10757770607966, 10757770607973, 10757770607980, 10757770607997, 10757770608000, 10757770608017, 10757770608024, 10757770608031, 10757770608048, 10757770608055, 10757770608062, 10757770608079, 10757770608093, 10757770608116, 10757770608130, 10757770608154; enVista Aspire IOL (EAU)/3Q24836, 3Q25105, 3Q25141, 3Q25142, 3Q25144, 3Q25145, 3Q25146, 3Q25223, 3Q25224, 3Q25225, 3Q25226, 3Q25227, 3Q25301, 3Q25302, 3Q25303, 3Q25304, 3Q25312, 3Q25313, 3Q25314, 3Q25315, 3Q25316, 3Q25317, 3Q25415, 3Q25416, 3Q25417, 3Q25444, 3Q25540, 3Q25542, 3Q25543, 3Q25623, 3Q25624, 3Q25627, 3Q25829, 3Q25830, 3Q25831, 3Q26401, 3Q26403, 3Q26404, 3Q26416, 3Q26417, 3Q26501, 3Q26502, 3Q26537, 3Q26541, 3Q26543, 3Q26607, 3Q26608, 3Q26611, 3Q26924, 3Q26925, 3Q26926, 3Q26941, 3Q26942, 3Q26943, 3Q26944, 3Q27245, 3Q27246, 3Q27247, 3Q27266, 3Q27267, 3Q27304, 3Q27305, 3Q27306, 3Q27307, 3Q27348, 3Q27349, 3Q27513, 3Q27514, 3Q27515, 3Q27606, 3Q27714, 3Q27715, 3Q27716, 3Q27718, 3Q27719, 3Q27802, 3Q27803, 3Q27804, 3Q27805, 3Q27933, 3Q27934, 3Q27935, 3Q27936, 3Q27937, 3Q28049, 3Q28050, 3Q28051, 3Q28213, 3Q28214, 3Q28216, 3Q28705, 3Q28706, 3Q28846, 3Q28847, 3Q28849, 3Q28850, 3Q28851, 3Q28852, 3Q28940, 3Q29002, 3Q29003, 3Q29004, 3Q29005, 3Q29107, 3Q29108, 3Q29155, 3Q29156, 3Q29157, 3Q29158, 3Q29251, 3Q29252, 3Q29265, 3Q29267, 3Q29268, 3Q29321, 3Q29322, 3Q29323, 3Q29324, 3Q29416, 3Q29417, 3Q29418, 3Q29419, 3Q29420, 3Q29539, 3Q29540, 3Q29541, 3Q29542, 3Q29543, 3Q29544, 3Q29601, 3Q29602, 3Q29603, 3Q29604, 3Q29716, 3Q29717, 3Q29718, 3Q29719, 3Q29721, 3Q29722, 3Q29819, 3Q29820, 3Q29821, 3Q29907, 3Q29908, 3Q30014, 3Q30015, 3Q30016, 3Q30108, 3Q30109, 3Q30110, 3Q30323, 3Q30324, 3Q30408, 3Q30409, 3Q30410, 3Q30510, 3Q30604, 3Q30605, 3Q30606, 3Q30712, 3Q30713, 3Q30714, 3Q30715, 3Q30716, 3Q30829, 3Q30830, 3Q31001, 3Q31002, 3Q31003, 3Q31004, 3Q31022, 3Q31127, 3Q31128, 3Q31129, 3Q31130, 3Q31159, 3Q31160, 3Q31161, 3Q31235, 3Q31333, 3Q31334, 3Q31335, 3Q31336, 3Q31337, 3Q31338, 3Q31409, 3Q31410, 3Q31416, 3Q31417, 3Q31505, 3Q31649, 3Q31709, 3Q31742, 3Q31743, 3Q31753, 3Q31805, 3Q31822, 3Q31902, 3Q31939, 3Q32026, 3Q32101, 3Q32153, 3Q32154, 3Q32415, 3Q32416, 3Q32505, 3Q32601, 3Q32602, 3Q32613, 3Q32617, 3Q32950, 3Q33055, 3Q33502, 3Q33523, 3Q33563, 3Q33601, 3Q33602, 3Q33621, 3Q33704, 3Q33740, 3Q35114, 3Q35231, 3Q35232, 3Q25102, 3Q25414, 3Q26402, 3Q26540, 3Q26542, 3Q26609, 3Q26610, 3Q27227, 3Q27717, 3Q27801, 3Q27931, 3Q27932, 3Q28215, 3Q28848, 3Q29159, 3Q29256, 3Q29325, 3Q29421, 3Q29605, 3Q29720, 3Q29906, 3Q30013, 3Q30254, 3Q30255, 3Q30511, 3Q30512, 3Q30821, 3Q30828, 3Q31037, 3Q31236, 3Q31504, 3Q31806, 3Q32027, 3Q32504, 3Q32507, 3Q32825, 3Q33006, 3Q33110, 3Q34643, 3Q34818/ 10757770608277, 10757770608284, 10757770608291, 10757770608307, 10757770608314, 10757770608321, 10757770608338, 10757770608345, 10757770608352, 10757770608369, 10757770608376, 10757770608383, 10757770608390, 10757770608406, 10757770608413, 10757770608420, 10757770608437, 10757770608444, 10757770608451, 10757770608468, 10757770608475, 10757770608482, 10757770608499, 10757770608505, 10757770608512, 10757770608529, 10757770608536, 10757770608543, 10757770608550, 10757770608567, 10757770608574, 10757770608581, 10757770608598, 10757770608604, 10757770608611, 10757770608628, 10757770608635, 10757770608642, 10757770608659, 10757770608666, 10757770608673, 10757770608680, 10757770608697, 10757770608703, 10757770608710, 10757770608727, 10757770608734, 10757770608741, 10757770608758, 10757770608765, 10757770608772, 10757770608789, 10757770608796, 10757770608802, 10757770608819, 10757770608826, 10757770608833; enVista Monofocal Toric IOL (ETEU)/3Q24827, 3Q25022, 3Q25243, 3Q25248, 3Q25250, 3Q25252, 3Q25402, 3Q25403, 3Q25428, 3Q25429, 3Q25430, 3Q25434, 3Q25435, 3Q25436, 3Q25437, 3Q25438, 3Q25441, 3Q25528, 3Q25532, 3Q25538, 3Q25552, 3Q25553, 3Q25556, 3Q25564, 3Q25739, 3Q25957, 3Q26018, 3Q26028, 3Q26065, 3Q26218, 3Q26242, 3Q26249, 3Q26349, 3Q26351, 3Q26532, 3Q26533, 3Q26649, 3Q26654, 3Q26656, 3Q26657, 3Q26825, 3Q26827, 3Q26828, 3Q26830, 3Q26831, 3Q26932, 3Q27228, 3Q27229, 3Q27238, 3Q27239, 3Q27241, 3Q27257, 3Q27259, 3Q27345, 3Q27433, 3Q27434, 3Q27436, 3Q27437, 3Q27459, 3Q27632, 3Q27806, 3Q27921, 3Q27922, 3Q27924, 3Q28024, 3Q28025, 3Q28027, 3Q28028, 3Q28029, 3Q28030, 3Q28032, 3Q28142, 3Q28143, 3Q28145, 3Q28146, 3Q28148, 3Q28149, 3Q28150, 3Q28238, 3Q28240, 3Q28925, 3Q28927, 3Q28928, 3Q28929, 3Q29143, 3Q29144, 3Q29145, 3Q29160, 3Q29161, 3Q29162, 3Q29163, 3Q29168, 3Q29170, 3Q29315, 3Q29316, 3Q29318, 3Q29430, 3Q29431, 3Q29434, 3Q29435, 3Q29436, 3Q29528, 3Q29531, 3Q29536, 3Q29652, 3Q29659, 3Q29660, 3Q29729, 3Q29730, 3Q29822, 3Q29823, 3Q29927, 3Q29929, 3Q30036, 3Q30038, 3Q30039, 3Q30040, 3Q30041, 3Q30146, 3Q30229, 3Q30231, 3Q30449, 3Q30451, 3Q30531, 3Q30650, 3Q30656, 3Q30659, 3Q30750, 3Q30752, 3Q30754, 3Q30804, 3Q30808, 3Q30935, 3Q31049, 3Q31052, 3Q31119, 3Q31120, 3Q31122, 3Q31124, 3Q31126, 3Q31306, 3Q31367, 3Q31453, 3Q31457, 3Q31551, 3Q31554, 3Q31629, 3Q31630, 3Q31635, 3Q31847, 3Q31852, 3Q31853, 3Q31870, 3Q31872, 3Q31940, 3Q31941, 3Q31942, 3Q32112, 3Q32114, 3Q32333, 3Q32447, 3Q32532, 3Q32633, 3Q32639, 3Q32852, 3Q32853, 3Q32854, 3Q33534, 3Q33627, 3Q33750, 3Q33942, 3Q34137, 3Q34138, 3Q34139, 3Q34140, 3Q34143, 3Q34255, 3Q34345, 3Q34451, 3Q34738, 3Q34743, 3Q34810, 3Q34813, 3Q35310, 3Q35542, 3Q35546, 3Q35755, 3Q35827, 3Q35924, 3R00428, 3R00632, 3R00928, 3R00930, 3R02340, 3R02573, 3R02731, 3R02837, 3R03436, 3R03939, 3Q24718, 3Q24719, 3Q24723, 3Q24724, 3Q24825, 3Q24826, 3Q24828, 3Q25023, 3Q25024, 3Q25042, 3Q25133, 3Q25134, 3Q25135, 3Q25136, 3Q25137, 3Q25240, 3Q25241, 3Q25242, 3Q25244, 3Q25245, 3Q25246, 3Q25247, 3Q25249, 3Q25251, 3Q25253, 3Q25254, 3Q25255, 3Q25256, 3Q25257, 3Q25336, 3Q25337, 3Q25338, 3Q25339, 3Q25340, 3Q25341, 3Q25342, 3Q25343, 3Q25431, 3Q25432, 3Q25433, 3Q25439, 3Q25440, 3Q25442, 3Q25443, 3Q25519, 3Q25520, 3Q25521, 3Q25523, 3Q25524, 3Q25525, 3Q25526, 3Q25527, 3Q25529, 3Q25530, 3Q25531, 3Q25533, 3Q25536, 3Q25537, 3Q25539, 3Q25544, 3Q25554, 3Q25555, 3Q25561, 3Q25562, 3Q25563, 3Q25565, 3Q25566, 3Q25635, 3Q25637, 3Q25645, 3Q25646, 3Q25734, 3Q25956, 3Q26001, 3Q26002, 3Q26019, 3Q26020, 3Q26021, 3Q26022, 3Q26023, 3Q26024, 3Q26025, 3Q26026, 3Q26027, 3Q26029, 3Q26030, 3Q26031, 3Q26032, 3Q26033, 3Q26034, 3Q26035, 3Q26064, 3Q26066, 3Q26067, 3Q26068, 3Q26219, 3Q26243, 3Q26244, 3Q26245, 3Q26246, 3Q26247, 3Q26248, 3Q26250, 3Q26251, 3Q26252, 3Q26253, 3Q26254, 3Q26335, 3Q26336, 3Q26337, 3Q26338, 3Q26339, 3Q26340, 3Q26341, 3Q26342, 3Q26343, 3Q26344, 3Q26345, 3Q26350, 3Q26352, 3Q26353, 3Q26530, 3Q26531, 3Q26534, 3Q26535, 3Q26536, 3Q26648, 3Q26650, 3Q26651, 3Q26652, 3Q26653, 3Q26655, 3Q26658, 3Q26826, 3Q26829, 3Q26832, 3Q26931, 3Q26933, 3Q26934, 3Q26935, 3Q26936, 3Q26937, 3Q26938, 3Q26939, 3Q26940, 3Q27231, 3Q27232, 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3Q32145, 3Q32147, 3Q32245, 3Q32247, 3Q32250, 3Q32251, 3Q32313, 3Q32314, 3Q32315, 3Q32316, 3Q32317, 3Q32324, 3Q32325, 3Q32326, 3Q32345, 3Q32427, 3Q32428, 3Q32430, 3Q32433, 3Q32435, 3Q32536, 3Q32538, 3Q32542, 3Q32648, 3Q32725, 3Q32729, 3Q32829, 3Q32833, 3Q32834, 3Q32836, 3Q32841, 3Q32919, 3Q32921, 3Q32927, 3Q33029, 3Q33551, 3Q33552, 3Q33553, 3Q33554, 3Q33634, 3Q33640, 3Q33705, 3Q33707, 3Q33903, 3Q33904, 3Q34442, 3Q34445, 3Q34446, 3Q34447, 3Q34616, 3Q34623, 3Q34748, 3Q34755, 3Q35170, 3Q35171, 3Q35326, 3Q35419, 3Q35828, 3Q35830, 3R03125/ 10757770618276, 10757770620743, 10757770620750, 10757770620767, 10757770620774, 10757770620781, 10757770620798, 10757770620804, 10757770620811, 10757770620828, 10757770620835, 10757770620842, 10757770620859, 10757770620866, 10757770620873, 10757770620880, 10757770620897, 10757770620903, 10757770620910, 10757770620927, 10757770620934, 10757770620941, 10757770620958, 10757770620965, 10757770620972, 10757770620989, 10757770620996, 10757770621009, 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10757770622075, 10757770622082, 10757770622099, 10757770622105, 10757770622112, 10757770622129, 10757770622136, 10757770622143, 10757770622150, 10757770622167, 10757770622174, 10757770622181, 10757770622198, 10757770622204, 10757770622211, 10757770622228, 10757770622235, 10757770622242, 10757770622259, 10757770622266, 10757770622273, 10757770622280, 10757770622297, 10757770622303, 10757770622310, 10757770622327, 10757770622334, 10757770622341, 10757770622358, 10757770622365, 10757770622372, 10757770622389, 10757770622396, 10757770622402, 10757770622419, 10757770622426, 10757770622433, 10757770622440, 10757770622457, 10757770622464, 10757770622471, 10757770622488, 10757770622495, 10757770622501

Distribution pattern

Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.

device · product 2 of 2

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Z-1680-2025

Recall number: Z-1680-2025
Initiated: March 27, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Bausch & Lomb Surgical, Inc.
Quantity: 48,237

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Description/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257, 3Q26538, 3Q26601, 3Q26603, 3Q26604, 3Q26679, 3Q26680, 3Q27353, 3Q27447, 3Q27457, 3Q27905, 3Q27907, 3Q28001, 3Q28002, 3Q28124, 3Q28125, 3Q28801, 3Q28901, 3Q28903, 3Q28904, 3Q28905, 3Q28906, 3Q29020, 3Q29021, 3Q29205, 3Q29266, 3Q29301, 3Q29302, 3Q29304, 3Q29305, 3Q29306, 3Q29401, 3Q29403, 3Q29405, 3Q29406, 3Q29545, 3Q29547, 3Q29548, 3Q29636, 3Q29637, 3Q29835, 3Q29837, 3Q30210, 3Q30310, 3Q30311, 3Q33702, 3Q33822, 3Q33918, 3Q33921, 3Q33924, 3Q33925, 3Q33928, 3Q34031, 3Q34034, 3Q34205, 3Q35006, 3Q35733, 3Q35735, 3Q35736, 3Q35738, 3Q35813, 3R01610, 3R01611, 3R02532, 3R02534, 3R02536, 3R02537, 3R02540, 3R02542, 3R02551, 3R02553, 3R02608, 3R02749, 3R02750, 3R02846, 3R03533, 3R03534, 3R03536, 3R03804, 3R03805, 3R03806, 3R04414, 3R04533, 3R05051, 3R05411, 3Q24749, 3Q24750, 3Q24751, 3Q24756, 3Q24763, 3Q24765, 3Q24766, 3Q24837, 3Q24842, 3Q24934, 3Q25115, 3Q25116, 3Q25117, 3Q25118, 3Q25119, 3Q25421, 3Q25422, 3Q25423, 3Q25424, 3Q25506, 3Q25834, 3Q25922, 3Q25923, 3Q26525, 3Q26527, 3Q26539, 3Q26602, 3Q26605, 3Q27252, 3Q27321, 3Q27322, 3Q27323, 3Q27324, 3Q27354, 3Q27456, 3Q27458, 3Q27906, 3Q27908, 3Q28003, 3Q28004, 3Q28011, 3Q28012, 3Q28802, 3Q29017, 3Q29018, 3Q29022, 3Q29203, 3Q29204, 3Q29303, 3Q29402, 3Q29404, 3Q29546, 3Q29550, 3Q29635, 3Q30211, 3Q30213, 3Q32503, 3Q33816, 3Q33817, 3Q33818, 3Q33819, 3Q33820, 3Q33821, 3Q33823, 3Q33920, 3Q33922, 3Q33926, 3Q33927, 3Q33929, 3Q34032, 3Q34033, 3Q34201, 3Q34202, 3Q34203, 3Q34204, 3Q34901, 3Q34903, 3Q35028, 3Q35031, 3Q35734, 3Q35812, 3R01612, 3R02136, 3R02535, 3R02539, 3R02541, 3R02543, 3R02601, 3R02602, 3R02603, 3R02607, 3R02710, 3R02711, 3R02845, 3R02848, 3R03411, 3R03502, 3R03643, 3R04411, 3R04412, 3R04531, 3R05048, 3R05049, 3R05052, 3R05627/ 10757770636478, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637543, 10757770637093, 10757770637109, 10757770637536, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208, 10757770637215, 10757770637222, 10757770637239, 10757770637246, 10757770637253, 10757770636485, 10757770637550, 10757770637277, 10757770637284, 10757770637291, 10757770637307, 10757770637314, 10757770637321, 10757770637338, 10757770637345, 10757770637352, 10757770637369, 10757770637376, 10757770637383, 10757770637390, 10757770637406, 10757770637413, 10757770637420, 10757770637437, 10757770637444, 10757770637451, 10757770637468, 10757770637475, 10757770637482, 10757770637499, 10757770637505, 10757770637512, 10757770637529, 10757770636492; enVista Envy Toric IOL (ETNU)/3Q25926, 3Q25930, 3Q26240, 3Q26426, 3Q26431, 3Q26435, 3Q26436, 3Q26440, 3Q26441, 3Q26621, 3Q26726, 3Q26727, 3Q26731, 3Q26819, 3Q26820, 3Q26910, 3Q26928, 3Q27216, 3Q27217, 3Q27219, 3Q27221, 3Q27223, 3Q27249, 3Q27250, 3Q27251, 3Q27264, 3Q27327, 3Q27330, 3Q27505, 3Q27506, 3Q27518, 3Q27742, 3Q27912, 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Distribution pattern

Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.