Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for…
Medical device recall Z-2154-2015. Published in FDA’s Enforcement Report on Jul 29, 2015.
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 29, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 42 states named
- 72,773 units; 52,787 units (US) 19,986 units (Foreign) 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?
Haptics breaking during lens loading and insertion.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
72,773 units; 52,787 units (US) 19,986 units (Foreign), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Produce Code: LI61AO and LI61SE. LOT #’s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 4456306, 4456316, 4456318, 4456319, 4456403, 4456406, 4456412, 4456413, 4456414, 4456415, 4456416, 4456703, 4456704, 4456707,…
Every code shown here, 2,000 characters
Produce Code: LI61AO and LI61SE. LOT #’s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 4456306, 4456316, 4456318, 4456319, 4456403, 4456406, 4456412, 4456413, 4456414, 4456415, 4456416, 4456703, 4456704, 4456707, 4456710, 4456711, 4456712, 4456713, 4456714, 4456715, 4456716, 4456717, 4456718, 4456719, 4456720, 4456721, 4456722, 4456723, 4456724, 4456725, 4456726, 4456727, 4456801, 4456803, 4456804, 4456805, 4456807, 4456808, 4456809, 4456810, 4456811, 4456812, 4456813, 4456814, 4456815, 4456816, 4456817, 4456818, 4456819, 4456820, 4456821, 4456822, 4456823, 4456824, 4456825, 4456826, 4456827, 4456828, 4456829, 4456830, 4456831, 4456832, 4456901, 4456902, 4456903, 4456904, 4456905, 4456906, 4456907, 4456908, 4456909, 4456910, 4456911, 4456912, 4457001, 4457002, 4457003, 4457004, 4457005, 4457006, 4457007, 4457008, 4457009, 4457010, 4457011, 4457012, 4457013, 4457014, 4457015, 4457016, 4457017, 4457018, 4457019, 4457020, 4457021, 4457022, 4457101, 4457102, 4457103, 4457104, 4457105, 4457106, 4457107, 4457108, 4457109, 4457110, 4457111, 4457401, 4457402, 4457403, 4457404, 4457406, 4457407, 4457408, 4457409, 4457410, 4457411, 4457412, 4457413, 4457414, 4457415, 4457416, 4457417, 4457418, 4457419, 4457420, 4457421, 4457422, 4457423, 4457424, 4457426, 4457427, 4457428, 4457501, 4457502, 4457503, 4457504, 4457505, 4457506, 4457507, 4457508, 4457509, 4457510, 4457511, 4457512, 4457513, 4457514, 4457515, 4457516, 4457517, 4457518, 4457519, 4457520, 4457521, 4457522, 4457523, 4457601, 4457602, 4457603, 4457604, 4457606, 4457607, 4457608, 4457609, 4457610, 4457611, 4457612, 4457613, 4457614, 4457615, 4457616, 4457617, 4457618, 4457619, 4457620, 4457701 4457702 4457703 4457704 4457705 4457706 4457707 4457708 4457709 4457710 4457711 4457712 4457713 4457714 4457715 4457716 4457717 4457718 4457719 4457720 4457721 4457722 4457723 4457724 4457725 4457726 4457727 4457801 4457802 4457803 4457804 4457805 4457806 4457807 4457808 4457809 4457810 4457811 4457812…
FDA’s list runs to 8,535 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.
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, Hawaii and Puerto Rico and countries of: Canada, Brazil, Argentina, Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Georgia, Greece, Kyrgyzstan, Norway, Russia, Ukraine, United Arab Emirates, China, Australia, India Malaysia, Korea, and Taiwan.
The states and territories these words name
42 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- 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.
The words say it went outside the United States too.
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 May 26, 2015.
- FDA classified it on Jul 20, 2015.
- FDA’s Enforcement Report published it on Jul 29, 2015.
- FDA terminated it on Aug 25, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bausch & Lomb Surgical, Inc., of Clearwater, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 8,535 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.