|Classification Name||aid, surgical, viscoelastic|
|Generic Name||ophthalmic viscosurgical device|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices.