PMA P080004S019

Device

iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System

Applicant

Hoya Surgical Optics, Inc.

PMA number

P080004

Supplement

S019

Product code

HQL

Decision date

2018-10-11

Classification

Intraocular Lens

Generic name

intraocular lens

Approval order statement

Approval for modifications to the coating of the stainless steel jigs used during the final washing process for the Hoya Medical Singapore Pte. Ltd. Manufacturing site located in Singapore.

Summary

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