💊 Drugs Class I - Dangerous
Failed Stability Specifications: Out of specification for viscosity.
Bausch & Lomb
27 recalls • • Categories: Prescription Drugs, Implants & Prosthetics, Other Drugs, Surgical Instruments, Other Medical Devices +1 more
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
🏥 Medical Devices Class I - Dangerous
The back cap separates from the body of the vitrectomy cutter.
💊 Drugs Class I - Dangerous
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
🏥 Medical Devices Class I - Dangerous
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
🏥 Medical Devices Class I - Dangerous
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
🏥 Medical Devices Class I - Dangerous
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
🏥 Medical Devices Class I - Dangerous
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
💊 Drugs Class I - Dangerous
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
🏥 Medical Devices Class I - Dangerous
Posterior fluidics modules installed in the system may need to be recalibrated.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.