nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous…
Medical device recall Z-1746-2013. 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?
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.
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: 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…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 21,751 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 21,751 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.