PMA P080004S021

Device

Hoya iSert and Clarisert Intraocular Lens

Applicant

Hoya Surgical Optics, Inc.

PMA number

P080004

Supplement

S021

Product code

HQL

Decision date

2018-02-01

Classification

Intraocular Lens

Generic name

intraocular lens

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).

Summary

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