Atlas FDA

SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blis

FDA device recall Z-0544-05 · posted 2005-02-16 · Terminated

Recall details

Recalling firm
Bausch & Lomb Inc
Reason for recall
Portion of lot contains lenses with incorrect refractive power.
Action taken
Letters issued dated February 4, 2005. The letters are flagged 'URGENT MEDICAL DEVICE RECALL'. Distributors are instructed to notify their customers to the retail (practitioner) level. All customers are instructed to return product.
Root cause
Other
Status
Terminated
Product code
LPL
Quantity affected
798 cartons distrib. by B&L, Rochester, NY
Distribution
There are 134 eye care practitioners, 191 mass retailers, 19 distributors, 14 consumers, and 3 mail order businesses.
Date initiated
2005-02-04
Date posted
2005-02-16
Date terminated
2005-10-28
Location
Rochester, NY

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