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Device | Hoya iSert and Clarisert Intraocular Lens |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVENUE CHINO HILLS, CA 91709 |
PMA Number | P080004 |
Supplement Number | S021 |
Date Received | 01/05/2018 |
Decision Date | 02/01/2018 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modifications to the Final Inspection Work Instruction for haptic scratches at the HOYA Surgical Optics manufacturing site located in Singapore for the HOYA iSert® and Clarisert Intraocular lens (IOLs). |