# K971832: Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80CC, Ivalon Eye Drain, 400CC, Ivalon Eye Wick

- Pathway: 510(k) (Traditional)
- Applicant: M-Pact Worldwide Management Corp.
- Decided: Jul 31, 1997 after 73 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- Recalls of this device: 2 (0 Class I)
- 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) Merocel Eye Drain 80cc: named in the summary without a submission number
- (no number) Merocel Eye Drain 400cc: named in the summary without a submission number
- (no number) Merocel Eye Wick 8-inch: named in the summary without a submission number
- (no number) Merocel Surgical Spears: named in the summary without a submission number

## Recalls of this device
- Oct 22, 2024 · Class II · Z-0798-2025: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Oct 22, 2024 · Class II · Z-0799-2025: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

## Indications for use
The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.

Source page: https://510kreport.com/device/K971832
Methodology: https://510kreport.com/methodology