Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Medical device recall Z-2153-2015. 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 SofPort Advanced Optics Aspheric Lens
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 4456710 4456711…
Every code shown here, 1,993 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 4457813 4457814 4457815 4457816 4457817 4457818 4457819 4457820 4457821 4457822 4458101 4458102 4458103 4458104 4458105 4458106 4458107 4458108 4458109 4458110 4458111 4458112…
FDA’s list runs to 8,352 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 8,352 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.