FDA (Devices) recall action 76874

Bausch & Lomb Inc Irb recalled 44 products on 2018-03-14

The FDA (Devices) publishes a recall like this one as 44 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 44 pages.

Products: 44
Announced: 2018-03-14
Critical: 0
Units: 54,416,956

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 44

ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LASEREDGE Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, 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.
Category
Distribution
0 states
HighFDA (Devices)··2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling LASEREDGE Knives for ophthalmic surgery because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because an atypical volume of complaints reported dull blades.
Product
LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7548ADB, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of dull blade complaints.
Product
LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1.2 million LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, 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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A, 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.
Category
Distribution
0 states