FDA-Device2015-07-29Class II
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Bausch & Lomb Surgical, Inc.
Hazard
Haptics breaking during lens loading and insertion.
Sold states
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.
Affected count
72,773 units. 52,787 units (US) - 19,986 units (Foreign)
Manufactured in
21 N Park Place Blvd, N/A, Clearwater, FL, United States
Products
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2153-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief