Hoya iSert and Clarisert Intraocular Lens
FDA premarket approval P080004/S021 · decided 2018-02-01
Approval details
- PMA number
- P080004
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hoya iSert and Clarisert Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2018-01-05
- Decision date
- 2018-02-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- 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).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |