SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch & Lomb, Waterford, Ireland.
FDA Recall Z-0544-05 · Posted 2005-02-16
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Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeLPL
Date Initiated2005-02-04
Date Terminated2005-10-28
Product Quantity798 cartons distrib. by B&L, Rochester, NY
Reason for Recall
Portion of lot contains lenses with incorrect refractive power.
Firm Action
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
Distribution Pattern
There are 134 eye care practitioners, 191 mass retailers, 19 distributors, 14 consumers, and 3 mail order businesses.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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