Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom…
Medical device recall Z-1747-2013. Published in FDA’s Enforcement Report on Jul 24, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 24, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 34 states named
- 3,361 units total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
3,361 units total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 5,167 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
34 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 10, 2013.
- FDA classified it on Jul 17, 2013.
- FDA’s Enforcement Report published it on Jul 24, 2013.
- FDA terminated it on Oct 17, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Staar Surgical Co., of Monrovia, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,167 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.