Forceps, Ophthalmic

Device Code: 4238

Product Code(s): HNR

Device Classification Information

Device Type ID4238
Device NameForceps, Ophthalmic
Regulation DescriptionManual Ophthalmic Surgical Instrument.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.4350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHNR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4238
DeviceForceps, Ophthalmic
Product CodeHNR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Ophthalmic Surgical Instrument.
CFR Regulation Number886.4350 [🔎]
Device Problems
Break
21
Material Fragmentation
12
Particulates
6
Device Dislodged Or Dislocated
4
Adverse Event Without Identified Device Or Use Problem
3
Device Handling Problem
3
Defective Device
3
Material Separation
2
Mechanical Jam
1
Detachment Of Device Component
1
Mechanical Problem
1
Mechanics Altered
1
Cannula
1
Inadequate Service
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
Metal Shedding Debris
1
Misconnection
1
Device Operational Issue
1
Total Device Problems 64
TPLC Last Update: 2019-04-02 20:45:21

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