SeeLens MF Intraocular Lens

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Page 1 of 21CONTENTS1. OBJECTIVES 22. EFFICACY AND SAFETY ASSESSMENTS 23. MEDICAL DEVICE SPECIFICATION AND ADMINISTRATION 34. METHODS 65. STATISTICAL METHODS 76. RESULTS (3 MONTHS) 77. RESULTS (9 TO 12 MONTHS) 148. INTRA-OPERATIVE COMPLICATIONS 169. POSTOPERATIVE COMPLICATIONS 1610. ADVERSE EVENTS 1811. CONCLUSIONS: 19
Page 2 of 211. OBJECTIVESThis report describes clinical experience with the SeeLens MF, Hanita Lenses’ novel multifocallens for cataract patients. It is a post CE mark authorization, prospective, non-comparativestudy.The clinical evaluation aims were: to evaluate visual acuity, Establish the A- constant of the IOLThis report summarizes the results of the 3 month investigation and the results of a 9 to 12month follow up of 8 bilateral implanted eyes (4 patients) and 10 unilateral implanted eyes (10patients) implanted with SeeLens MF.The key safety and efficacy parameters are:Best Corrected Visual Acuity (BCVA)2. EFFICACY AND SAFETY ASSESSMENTSThe efficacy and safety assessments were determined as defined by and according to the ISO11979 directive. The following are the demands required by the directive:1. Post Operative BCVA of at least 6/12 (20/40) within 88% of patients' population. For the"best cases" patients, BCVA 6/12 (20/40) or better, for at least 94% of the patients.(Requirements defined by ISO 11979-7 2006 for a sample size of 100 patients).2. IOL related Post Operative complication and Adverse Events equal to or less then theallowed rate defined by ISO 11979-7 2006.
Page 1: 1. HANITALENSESClinical EvaluationP
Page 5 and 6: Page 4 of 21An increasingly importa
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Page 11 and 12: Page 10 of 21FIGURE 5 NOVAK RESULTS
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Page 15 and 16: Page 14 of 217. RESULTS (9 TO 12 MO
Page 17 and 18: Page 16 of 218. INTRA-OPERATIVE COM
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Page 21: Page 20 of 21Dr. Paparo patients we

SeeLens MF Intraocular Lens

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