Clinical Evaluation 3-month Follow-up Report Of ... - Hanita Lenses

עדשות חניתהHanita Lensesf. Adverse Events as defined by ISO 11979-7 200114of 16Adverse EventMaximal allowablerate as defined byISO 11979-7 2001 ;100 subjectsScore / measurementRate ofadverseeffectoccurred atthis studyPass/FailCystoid macular 6% No / Yes 0 % PassoedemaHyphema 5% 0 1 2 3 4 0% PassHypopyon 1% Measure in mm. 0% PassIntraocular 1% 0% PassinfectionLens dislocation 1% Measure in mm. 0% PassPupillary block 1% No / Yes 0% PassRetinaldetachmentSecondarySurgicalintervention(eccluding retinaldetachment andposteriorcapsulotomy)1% No / Yes 0% Pass2% No / Yes, specify 0% PassCorneal stroma 1% 0 1 2 3 4 0% PassoedemaCystoid macular 2% No / Yes 0% PassoedemaIritis 1% 0 1 2 3 4 0% PassRaised IOP req.treatment2% 0% PassAs shown in table 3, no adverse event was reported in 100% of SeeLens HP implanted eyes,in a sample size of 20 patients.Thus, it can be concluded that the SeeLens HP’s safety is fully in accordance to the ISO11979-7 2001This information supports the conclusions that were previously presented, and reassures thatthe SeeLens HP is a safe high quality predictable lens.Hanita Lenses Intraocular & Contact Lensesעדשות חניתהעדשות מגע ועדשות השתלה תוך-עינית•קיבוץ חניתה • 88885 www.hanitalenses.com Kibbutz Hanita 22885 Israel • Tel. 972-4-9950 700• Fax: 972-4-9950 755 •