Class 2 Device Recall STAAR Surgical Afinity IOL

• Date Initiated by Firm: June 10, 2013
• Date Posted: July 17, 2013
• Recall Status: Terminated on October 17, 2013
• Recall Number: Z-1747-2013
• Recall Event ID: 65558
• PMA Number: P990013
• Product Classification: intraocular lens - Product Code HQL
• Product: Afinity CQ2015A Intraocular Lens; ; The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
• Code Information: Serial Numbers: B377178 B377469 B377877 B378928 B379032 B379638 B380197 B380796 B377192 B377473 B377879 B378940 B379048 B379643 B380200 B380800 B377193 B377480 B377880 B378945 B379062 B379645 B380206 B380801 B377194 B377481 B377883 B378946 B379063 B379646 B380208 B380803 B377195 B377482 B377885 B378947 B379066 B379650 B380214 B380807 B377196 B377485 B377887 B378949 B379093 B379652 B380227 B380816 B377197 B377487 B377888 B378951 B379095 B379653 B380230 B381000 B377200 B377488 B377889 B378953 B379096 B379660 B380235 B381001 B377205 B377490 B377890 B378954 B379099 B379661 B380245 B381009 B377208 B377491 B377894 B378955 B379100 B380060 B380246 B381011 B377211 B377493 B378097 B378956 B379101 B380070 B380251 B381012 B377213 B377495 B378099 B378957 B379103 B380071 B380257 B381014 B377214 B377496 B378107 B378958 B379104 B380072 B380261 B381017 B377216 B377497 B378110 B378959 B379106 B380073 B380265 B381019 B377217 B377804 B378111 B378960 B379107 B380078 B380270 B381021 B377232 B377812 B378112 B378961 B379110 B380081 B380271 B381022 B377236 B377816 B378122 B378963 B379111 B380084 B380272 B381024 B377238 B377819 B378123 B378964 B379112 B380085 B380273 B381026 B377239 B377820 B378124 B378965 B379114 B380087 B380274 B381028 B377241 B377821 B378126 B378967 B379115 B380088 B380280 B381029 B377243 B377822 B378130 B378968 B379117 B380091 B380281 B381030 B377245 B377824 B378131 B378969 B379119 B380092 B380283 B381032 B377248 B377825 B378132 B378970 B379121 B380093 B380285 B381034 B377249 B377827 B378135 B378972 B379123 B380094 B380286 B381036 B377253 B377828 B378137 B378973 B379125 B380097 B380287 B381037 B377423 B377829 B378144 B378976 B379129 B380098 B380288 B381038 B377426 B377830 B378145 B378979 B379131 B380102 B380290 B381039 B377428 B377831 B378148 B378981 B379132 B380106 B380291 B381040 B377429 B377834 B378156 B378982 B379133 B380108 B380519 B381041 B377432 B377839 B378160 B378986 B379134 B380118 B380529 B381051 B377435 B377842 B378899 B378990 B379135 B380125 B380548 B381052 B377437 B377843 B378901 B378991 B379141 B380129 B380554 B381054 B377440 B377844 B378902 B378993 B379145 B380135 B380560 B381057 B377441 B377845 B378906 B378994 B379147 B380137 B380561 B381060 B377442 B377847 B378909 B379000 B379148 B380143 B380562 B381071 B377443 B377848 B378911 B379002 B379156 B380152 B380563 B381073 B377444 B377849 B378913 B379003 B379162 B380154 B380564 B381078 B377445 B377852 B378915 B379005 B379165 B380156 B380573 B381079 B377446 B377855 B378917 B379006 B379168 B380159 B380575 B381083 B377447 B377856 B378918 B379010 B379170 B380162 B380580 B381087 B377448 B377857 B378919 B379012 B379171 B380163 B380585 B381089 B377450 B377860 B378920 B379013 B379174 B380178 B380586 B381091 B377455 B377861 B378923 B379017 B379176 B380186 B380588 B381093 B377457 B377862 B378924 B379020 B379183 B380187 B380594 B381094 B377459 B377863 B378925 B379021 B379189 B380190 B380595 B381095 B377460 B377873 B378926 B379022 B379627 B380191 B380597 B381096 B377466 B377875 B378927 B379030 B379637 B380193 B380600 B381099 B381102 B381476 B382514 B383250 B384698 B385137 B381104 B381478 B382544 B383252 B384699 B385143 B381105 B381488 B382546 B383256 B384703 B385144 B381106 B381493 B382547 B383257 B384797 B385147 B381107 B381516 B382548 B383912 B385006 B385158 B381109 B381518 B382554 B383914 B385015 B385171 B381112 B381519 B382555 B383930 B385016 B385650 B381114 B381521 B382557 B383932 B385017 B385651 B381116 B381529 B382558 B383948 B385021 B385652 B381118 B381539 B382636 B384045 B385022 B385655 B381119 B381540 B382637 B384054 B385023 B385656 B381121 B381542 B382645 B384058 B385026 B385658 B381122 B381543 B382647 B384063 B385030 B385659 B381123 B381545 B382648 B384066 B385031 B385965 B381124 B382384 B382652 B384067 B385032 B385967 B381127 B382386 B382658 B384068 B385033 B385968 B381130 B382388 B382660 B384071 B385035 B385987 B381140 B382389 B382661 B384072 B385037 B386070 B381142 B382392 B382662 B384077 B385043 B386081 B381147 B382396 B382669 B384081 B385044 B386131 B381168 B382400 B382672 B384085 B385050 B386179 B381175 B382401 B382679 B384089 B385058 B386228 B381176 B382416 B382683 B384091 B385074 B386250 B381177 B382423 B382686 B384096 B385079 B386258 B381178 B382428 B382687 B384097 B385091 B386259 B381182 B382429 B382688 B384101 B385092 B386260 B381183 B382430 B382692 B384183 B385093 B386263 B381185 B382432 B382693 B384184 B385094 B386265 B381186 B382437 B382702 B384186 B385096 B386266 B381189 B382438 B382709 B384187 B385098 B386930 B381191 B382441 B382710 B384188 B385099 B386932 B381192 B382442 B382711 B384190 B385101 B386943 B381195 B382446 B382719 B384193 B385102 B386953 B381199 B382448 B382722 B384194 B385104 B381201 B382450 B382743 B384202 B385105 B381202 B382453 B382761 B384203 B385108 B381203 B382455 B382776 B384207 B385109 B381204 B382456 B382790 B384208 B385112 B381206 B382457 B382801 B384212 B385116 B381208 B382465 B382807 B384213 B385118 B381211 B382471 B383231 B384215 B385119 B381213 B382472 B383235 B384670 B385120 B381216 B382484 B383237 B384675 B385121 B381220 B382485 B383238 B384677 B385122 B381223 B382505 B383240 B384682 B385125 B381228 B382509 B383246 B384684 B385127 B381466 B382512 B383247 B384686 B385129
• Recalling Firm/ Manufacturer: Staar Surgical Co.; 1911 Walker Ave; Monrovia CA 91016-4846
• For Additional Information Contact: 626-303-7902
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Material/Component Contamination
• Action: The firm, STAAR Surgical, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated June 10, 2013 to all the customers that received a limited number of nanoFLEX CC4204A and Afinity CQ2015 Intraocular lenses. The letter described the product, problem and actions to be taken. The customers were instructed to check your inventory; remove any lenses from the attached list; contact STAAR Surgical Customer Service for Returns Goods Authorization Number via phone: 1-800-352-7842; email: customerservice@staar.com; and/or fax: 1-800-952-4923; return listed lenses to STAAR Surgical; complete and return the attached response form by fax to Customer Service at (800) 952-4923, and pass this notice on to all those who need to be aware within your organization or any organization where the devices have been transferred. If you have any questions or concerns regarding the product return, contact STAAR Surgical Customer Service at (800) 352-7842.
• Quantity in Commerce: 3,361 units total
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = HQL and Original Applicant = STARR SURGICAL CO.