UNKNOWN RIGID GAS PERMEABLE CONTACT LENS
Received Oct 31, 2012
Report 1313525-2012-00037 · MDR key 2820630
Device
Generic name
None
Manufacturer
Bausch & LombProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bacterial Infection
Narrative
Description of Event or Problem
THE ATTACHED ARTICLE REPORTS A STUDY AIMED TO DETERMINE THE PREVALENCE OF CONTACT LENS RELATED COMPLICATIONS IN A TERTIARY EYE CARE CENTER IN (B)(6). THE ARTICLE REPORTS COMPLICATIONS ASSOCIATED WITH VARIOUS CONTACT LENS PRODUCTS. TABLE 2 SUMMARIZES THE VARIED COMPLICATIONS. TABLE 4 SUMMARIZES THE COMPLICATIONS BY LENS MATERIAL. HOWEVER, THE ARTICLE AND TABLE DO NOT PROVIDE DETAIL TO DETERMINE THE SPECIFIC COMPLICATIONS ASSOCIATED WITH THE IDENTIFIED LENS MATERIALS. THE AUTHOR OF THE ARTICLE WAS CONTACTED FOR ADDITIONAL INFO REGARDING THE CASES OF COMPLICATIONS AND RESPONDED THAT THE CASES WERE NOT CATEGORIZED BY MATERIAL OR BRAND AND THERE IS NO FURTHER INFO. TABLE 2 INDICATES THERE WERE EIGHT CASES OF MICROBIAL KERATITIS. OF THE EIGHT CASES, SEVEN WERE ASSOCIATED WITH THE SOFT CONTACT LENS MATERIALS, AND ONE PT WAS AN RGP WEARER. IT IS NOT KNOWN IF THE PTS WERE WEARING A BAUSCH AND LOMB LENS. HOWEVER, THE POSSIBILITY OF AN EVENT BEING ASSOCIATED WITH A BAUSCH AND LOMB MATERIAL CANNOT BE RULED OUT. THEREFORE, THE EIGHT INFECTIOUS KERATITIS CASES ARE BEING REPORTED.