BunnyLens AF - Hanita Lenses

Page 18 of 22h. Adverse EventsTable 5: Adverse Events as Defined by ISO 11979-7 2006:Adverse EventSPErate 1(%)Number of subjects = 100Maximalallowablerate (%)Max. numberof casesallowedRate ofadverse effectoccurred at thisstudyNumber ofadverseeventscasesPass / FailCumulative (total number of occurrences at any time postoperative):Cystoid macular oedema 3.0% 8.9% 6 5 % 2 2 PassHypopyon 0.3% 3.0% 1 0% 0 PassEndophthalmitis 3 0.1% 3.0% 1 0% 0 PassLens dislocation fromposterior chamber0.1% 3.0% 1 0% 0 PassPupillary block 0.1% 3.0% 1 0% 0 PassRetinal detachment 0.1% 3.0% 1 0% 0 PassSecondary surgical 0.1% 4.2% 2 0% 0 Passintervention 4Persistent (total number of occurrences at 3 months postoperative):Corneal stroma oedema 0.1% 3.0% 1 0% 0 PassCystoid macular oedema 0.1% 4.2% 2 2.5% 1 PassIritis 0.1% 3.0% 1 0% 0 PassRaised IOP req.treatment0.1% 4.2% 2 0% 0 PassAs shown in table 6, 95% of 44 implanted eyes did not reported any adverse events. 5% ofpatients presented CME, which is acceptable rate in cataract surgery.Thus, it can be concluded that safety of BunnyLens AF is in accordance to the ISO 11979-72006.1 SPE (safety and performance endpoint) rate is the target rate for each event.2 N09, N133 Endophthalmitis is defined as inflammatory reaction (sterile or infectious) involving the vitreous body.4 Excludes posterior capsulotomies.Hanita Lenses Intraocular & Contact Lensesעדשות חניתהעדשות מגע ועדשות השתלה תוך-עינית•קיבוץ חניתה • 88222 www.hanitalenses.com Kibbutz Hanita 22885 Israel • Tel. 972-4-9950 700• Fax: 972-4-9950 755 •