FDA Device

OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.

Hazard

Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.

What You Should Do

Remedy

Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.

Products

OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.
Brand
Bausch & Lomb Inc
UPC
Lot R21000211

Units Affected

2,081 / 6-packs