A consumer reported that he is "suffering from a chronic infection in the left eye due to poor quality lenses." communications with the consumer indicated the consumer first used 3 lenses comfortably but felt discomfort while using the 4th pair of lenses, theses lenses were discarded.The consumer wore a fresh pair of lenses and reported the problem still persisted.After which the consumer discontinued the lenses and contacted an ophthalmologist.A report from the practitioner indicates the consumer presented with symptoms of pain, blurring and redness in the left eye.The practitioner observed; bulbar injection, conjunctivitis, external lid/lashes abnormalities (edema) and hypopyon of the left eye.In addition, the practitioner observed corneal edema, staining and infiltrates in the central 4mm x4mm of the cornea, a corneal abrasion/erosion, specified as central sloughing, the corneal abrasion/erosion penetrated bowman¿s membrane, left a residual scar, and it is located in the central 6mm of the cornea.The practitioner also indicated, the patient had an infectious corneal ulcer in the central 4mm x 4mm ring infiltrate, has microbial keratitis and neovascularization and the new blood vessels extend into the central 6 mm of the cornea.The practitioner indicated there is a new corneal scar in the central 4mm and that the patient has permanent loss of vision.Cultures were taken and the results were positive for pseudomonas aeruginosa.The practitioner's diagnosis was left eye infectious keratitis with hypopyon.Patient was provided fortified vancomycin and fortified cefitazidime.The patient was instructed to stay at the hospital for 5 days while receiving this treatment and to temporary suspend contact lens wear.Other treatment provided was reported as use of cycloplegics.In the practitioner¿s opinion, the likely cause of the event was contact lens induced keratitis.The practitioner indicated the event was not life threatening; however, it did result in permanent impairment, and the event did need medical or surgical intervention to preclude permanent impairment of a body function/structure.Information related to the patient¿s lens care practices were not available.The patient is continuing to receive treatment.
|
Additional information: a review of the lot device history records concludes that the product was manufactured, packaged, and released according to global and plant product specifications.Based on available information, no causal factors can be determined and no conclusion can be drawn.
|