Serious injury involving on person 1. On 7/08/98, pt experienced redness and soreness in left eye. Dr diagnosed corneal ulcer and treated with polysporin and cellufresh as needed lens model/water content: cib asoft standard 38%: lot number: unk; eye involved: left; refraction: 8. 3 13. 8-05. 25; duration of use (in months) wearing modality: 12; number days lens worn: unk; last visit to dr prior to symptoms: unk; type of lens care system used; chemical: name of disinfection system used; optifree; was homemade saline used; no; days lens worn between cleaning and disinfecting; 1;days lens worn between cleaning and symptoms: 1; days between symptoms and calling dr; 14; self-treatment by pt; unk; hand washing before lens manipulation: unk; ulcer location: peripheral; visual acuity before symptoms: unk; visual acuity after symptoms: unk; results of culture: none taken: results of corneal biopsy and/or scrapings:unk; clincial diagnoisis: corneal ulcer: treatment administered: 1 cm ribbon of polysporin followed by cellufrest as needed; prognosis: clear within 2 weeks;.

On 8/26/1998 an mdr was filed with the fda for one of cvc's lens products, cibasoft std contact lenses. A total of 2 lenses were rec'd from canada for eval under complaint # can980806101143. The lot number was unknown therefore; an investigation of the lot could not be performed. Lens results were as follows: lens #1: within specification. Lens #2: an unidentified spot (appeared to be rust) was detected on the front surface of the lens. The lens was sent to bti for further testing to properly identify the defect. Bti results: the orange spot was a slightly raised area on the front surface of the lenses containing iron and sulfur. It did not extend to the back surface. The rust spot would not have contacted the cornea unless the lens was worn inverted. Co will continue to monitor trends with this product. Due to the eval results for this complaint the investigation is considered closed.