# K980844: Surgidev Silicone Punctum Plug

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vision Science
- Decided: May 11, 1998 after 68 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Soft Plug™ (marketed by Oasis): named in the summary without a submission number
- (no number) Punctum Plug (marketed by FCI Ophthalmics): named in the summary without a submission number
- (no number) Tapered-Shaft Punctum Plug (marketed by Eagle Vision and Ciba Vision): named in the summary without a submission number

## Indications for use
The Surgidev Silicone Punctum Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of the punctum. The Surgidev Silicone Punctum Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as corneal ulcers, conjunctivitis, pterygium, blepharitis, keratitis, red lid margins, recurrent chalazions, recurrent corneal erosion, filamentary keratitis and other external eye diseases. When indicated the Surgidev Silicone Punctum Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing ocular dryness secondary to contact lens use may also be aided by Silicone Punctum Plugs.

Source page: https://510kreport.com/device/K980844
Methodology: https://510kreport.com/methodology