FDAFDA · Food and drugs·Recall number Z-1746-2013
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
Published July 24, 2013 · Recall initiated: June 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Staar Surgical Co.
- Distributor
- Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.
- Lot
- Serial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B377627 B377915 B378041 B378216 B377009 B377130 B377348 B377531 B377632 B377918 B378042 B378217 B377010 B377131 B377349 B377532 B377635 B377920 B378043 B378218 B377013 B377142 B377350 B377536 B377640 B377921 B378051 B378219 B377016 B377151 B377352 B377538 B377643 B377923 B378053 B378220 B377020 B377153 B377353 B377539 B377650 B377926 B378057 B378222 B377024 B377154 B377354 B377541 B377651 B377936 B378058 B378223 B377025 B377158 B377355 B377542 B377655 B377940 B378059 B378225 B377026 B377161 B377356 B377543 B377660 B377942 B378062 B378227 B377029 B377165 B377357 B377544 B377669 B377943 B378063 B378228 B377030 B377167 B377358 B377548 B377678 B377944 B378065 B378231 B377032 B377168 B377359 B377550 B377681 B377945 B378067 B378234 B377034 B377171 B377360 B377551 B377686 B377946 B378068 B378235 B377035 B377172 B377361 B377552 B377687 B377950 B378070 B378236 B377036 B377255 B377362 B377553 B377689 B377959 B378071 B378239 B377037 B377258 B377363 B377554 B377690 B377960 B378072 B378241 B377038 B377259 B377366 B377555 B377691 B377963 B378075 B378242 B377040 B377262 B377367 B377557 B377692 B377964 B378076 B378248 B377041 B377263 B377368 B377558 B377693 B377971 B378077 B378255 B377042 B377264 B377369 B377559 B377700 B377972 B378081 B378257 B377043 B377267 B377370 B377560 B377706 B377974 B378082 B378258 B377045 B377270 B377371 B377561 B377707 B377975 B378083 B378259 B377049 B377273 B377372 B377562 B377713 B377979 B378086 B378263 B377054 B377276 B377374 B377563 B377718 B377983 B378087 B378264 B377057 B377278 B377376 B377564 B377721 B377988 B378165 B378265 B377061 B377285 B377377 B377567 B377727 B377991 B378171 B378267 B377062 B377288 B377378 B377569 B377730 B377993 B378172 B378268 B377065 B377290 B377383 B377570 B377741 B377998 B378173 B378269 B377068 B377291 B377384 B377571 B377744 B377999 B378175 B378271 B377070 B377297 B377386 B377572 B377745 B378000 B378177 B378274 B377074 B377298 B377388 B377573 B377746 B378002 B378178 B378275 B377081 B377301 B377389 B377575 B377748 B378006 B378179 B378277 B377083 B377305 B377396 B377576 B377756 B378008 B378180 B378282 B377085 B377306 B377397 B377578 B377759 B378019 B378182 B378284 B377087 B377308 B377400 B377579 B377764 B378020 B378186 B378286 B377095 B377314 B377402 B377587 B377765 B378024 B378188 B378291 B377096 B377315 B377409 B377588 B377766 B378027 B378190 B378298 B377099 B377317 B377411 B377594 B377769 B378028 B378192 B378299 B377102 B377319 B377414 B377596 B377774 B378029 B378194 B378302 B377105 B377323 B377415 B377598 B377776 B378030 B378198 B378303 B377106 B377324 B377416 B377599 B377900 B378031 B378199 B378304 B377113 B377332 B377420 B377601 B377901 B378032 B378206 B378306 B377114 B377336 B377421 B377602 B377902 B378034 B378208 B378307 B377118 B377337 B377422 B377603 B377904 B378035 B378209 B378308 B377120 B377338 B377498 B377610 B377906 B378036 B378210 B378311 B377121 B377341 B377511 B377616 B377908 B378038 B378211 B378312 B378314 B378415 B378505 B378597 B378750 B378822 B379221 B379329 B378316 B378416 B378506 B378600 B378755 B378824 B379223 B379331 B378317 B378418 B378507 B378601 B378757 B378825 B379226 B379333 B378319 B378421 B378509 B378605 B378759 B378831 B379228 B379334 B378320 B378425 B378510 B378607 B378760 B378833 B379230 B379335 B378321 B378426 B378511 B378611 B378761 B378834 B379231 B379337 B378322 B378427 B378516 B378612 B378762 B378835 B379232 B379343 B378326 B378428 B378517 B378625 B378763 B378836 B379233 B379345 B378328 B378429 B378518 B378626 B378765 B378838 B379235 B379347 B378331 B378430 B378522 B378628 B378766 B378842 B379236 B379349 B378332 B378431 B378523 B378632 B378767 B378847 B379237 B379354 B378334 B378433 B378526 B378634 B378768 B378848 B379239 B379357 B378337 B378438 B378529 B378639 B378769 B378852 B379240 B379363 B378351 B378441 B378530 B378640 B378770 B378853 B379243 B379365 B378353 B378444 B3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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