# K032104: Amniolens

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tissue, Inc.
- Decided: Dec 12, 2003 after 157 days
- Product code: NQB (Conformer, Ophthalmic, Biological Tissue)
- Device class: 2
- Regulation: 21 CFR 886.3130
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921221 (1992). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921221: Sterile/Single Use Symblepharon Ring, Storz Instrument Co. (1992) Summary page 1.

## Most influential descendants
- K053622: Surgisis Ocular Graft (2006), 2 descendants of its own
- K090078: Kerasys Bioengineered Lamellar Patch Graft (2009), 1 descendant of its own
- K223074: CorNeat EverPatch (2023), 0 descendants of its own

## Recalls of this device
- Nov 10, 2020 · Class II · Z-0550-2021: Potential exposure of product to microbial contamination.
- Nov 10, 2020 · Class II · Z-0552-2021: Potential exposure of product to microbial contamination.
- Nov 10, 2020 · Class II · Z-0551-2021: Potential exposure of product to microbial contamination.

## Indications for use
The ProKeraTM is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred. The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.

Source page: https://510kreport.com/device/K032104
Methodology: https://510kreport.com/methodology