Home / Recalls / Bausch & Lomb Inc Irb / Z-0852-2018

Z-0852-2018 Class II Terminated

Recalled by Bausch & Lomb Inc Irb — Rochester, NY

Recall Details

Product Type
Devices
Report Date
March 14, 2018
Initiation Date
March 3, 2017
Termination Date
June 25, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,236,749 knives in total

Product Description

LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Reason for Recall

The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.

Distribution Pattern

US Nationwide Distribution

Code Information

none

Other recalls by Bausch & Lomb Inc Irb

  • Z-0891-2018 Class II — LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, (March 3, 2017)
  • Z-0878-2018 Class II — LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE (March 3, 2017)
  • Z-0888-2018 Class II — LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STER (March 3, 2017)
  • Z-0864-2018 Class II — LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT C (March 3, 2017)
  • Z-0856-2018 Class II — LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, (March 3, 2017)
  • Z-0863-2018 Class II — LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE (March 3, 2017)
  • Z-0876-2018 Class II — LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE (March 3, 2017)
  • Z-0851-2018 Class II — LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE (March 3, 2017)
  • Z-0871-2018 Class II — LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT (March 3, 2017)
  • Z-0862-2018 Class II — LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STE (March 3, 2017)