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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ophthalmic syringe
Definition An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.
Product CodeQLY
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRIBOFILM RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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