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MoistureLoc Lens Solution Saga Continues: B&L Gets FDA Warning Letter

This article was originally published in The Gray Sheet

Executive Summary

Bausch & Lomb has already addressed a majority of the 15 contact lens solution manufacturing and postmarket surveillance violations cited by FDA in a recent 1warning letter, according to the company

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B&L lens care solution facility

Bausch & Lomb's Greenville, S.C., contact lens solution plant clears FDA inspection June 29. The Greenville plant had manufactured the firm's ReNu with MoistureLoc lens care solution, which was withdrawn from the market last May after being linked to reports of fusarium keratitis infections. FDA issued a warning letter to the plant in October, citing failure to promptly notify the agency of adverse events, inadequate process validation, and lack of procedures to prevent product or equipment contamination, among other quality systems concerns (1"The Gray Sheet" Nov. 13, 2006, p. 18). According to B&L, FDA is now satisfied that the firm has completed all of its corrective actions...

B&L lens care solution facility

Bausch & Lomb's Greenville, S.C., contact lens solution plant clears FDA inspection June 29. The Greenville plant had manufactured the firm's ReNu with MoistureLoc lens care solution, which was withdrawn from the market last May after being linked to reports of fusarium keratitis infections. FDA issued a warning letter to the plant in October, citing failure to promptly notify the agency of adverse events, inadequate process validation, and lack of procedures to prevent product or equipment contamination, among other quality systems concerns (1"The Gray Sheet" Nov. 13, 2006, p. 18). According to B&L, FDA is now satisfied that the firm has completed all of its corrective actions...

B&L lens solution troubles

Preliminary 2006 year-end results released March 6 show Bausch & Lomb's sales declined 3% to $2.29 billion in 2006 primarily because lens care sales were down 21% for the year to $414.2 million. The firm estimates its share of the U.S. multipurpose solutions market dropped from 30% in 2005 to 18% at the end of 2006 because of a recall of ReNu with MoistureLoc (1"The Gray Sheet" Nov. 13, 2006, p. 18). Bausch & Lomb expects to officially file its 2006 report by April 30. Also March 6, Bausch & Lomb voluntarily recalled 12 lots of ReNuMultiPlus lens care solution, citing an elevated level of trace iron that may indicate a shortened shelf life for the product. The firm does not expect the latest recall to have a significant financial impact...

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