Definition: An Ophthalmic Sealant Is Intended To Maintain An Incision Closure And Aid In Preventing Fluid Egress From Incisions In The Eye.
| Device Type ID | 4453 |
| Device Name | Ophthalmic Sealant |
| Physical State | A Topical Liquid/hydrogel/material Which Creates A Temporary Adherent Closure. |
| Technical Method | An Ophthalmic Sealant Device Is Applied To An Incision In The Eye Following An Intraocular Surgery. Once Applied To The Surface Of The Eye, The Device Adheres To The Ocular Tissue And Aids In Incision Closure And Prevention Of Fluid Egress. |
| Target Area | Eye |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PFZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4453 |
| Device | Ophthalmic Sealant |
| Product Code | PFZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Insufficient Information | 2 |
| Total Device Problems | 2 |