Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implan

FDA device recall Z-2154-2015 · posted 2015-07-20 · Terminated

Recall details

Recalling firm

Bausch & Lomb Surgical, Inc.

Reason for recall

Haptics breaking during lens loading and insertion.

Action taken

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 surgery before your full return can be processed, please contact your B&L representative to expedite shipment of the IOL. For questions contact Bausch + Lomb at (800) 338-2020.

Root cause

Device Design

Status

Terminated

Product code

HQL

Quantity affected

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,

Date initiated

2015-05-26

Date posted

2015-07-20

Date terminated

2016-08-25

Location

Clearwater, FL