Recall Z-2153-2015 ยท HQL Intraocular Lens
Bausch & Lomb Surgical, Inc.
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
| Date | Jul 20, 2015 (initiated May 26, 2015) |
| Status | Terminated |
| Reason | Haptics breaking during lens loading and insertion. |
| Root cause | Device Design |
| Action | Bausch + Lomb sent an Urgent Medical Device Recall letter dated May 29, 2015 to their custometers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: segregate the identified IOLs, return the IOLs through your B&L representative or by using the prepaid shipping label included in this package, order replacement product through customer service (800) 338-2020 or your B&L representative and complete & return the acknowledgement form included in this package. Customers were advised that if replacement product is needed for a scheduled surg |
| Quantity | 72,773 units. 52,787 units (US) - 19,986 units (Foreign) |
| Distribution | 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, Belgiu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.