Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga recall — FDA Z-3267-2018
The back cap separates from the body of the vitrectomy cutter.
Overview of recall records associated with Bausch & Lomb, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 17, Class III: 3.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
The back cap separates from the body of the vitrectomy cutter.
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
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.
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…
This page summarizes recall records in which the official source identifies Bausch & Lomb, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.