Conformer, Ophthalmic, Biological Tissue
Ophthalmic · 21 CFR 886.3130
The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
Recent MDR events
54 adverse event reports on file
- PROKERA SLIMJul 13, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00039
- PROKERA SLIMJul 13, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00040
- PROKERA SLIMJun 11, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00034
- PROKERA SLIMMay 27, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00033
- PROKERA SLIM (PKS)May 19, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00029
- PROKERA SLIMMay 5, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00027
- PROKERA SLIMMay 5, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00028
- PROKERAMar 30, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00025
- PROKERAMar 18, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00015
- PROKERAMar 18, 2026InjuryBiotissue Holdings Inc.3009809074-2026-00017
Event type breakdown
Recalls
3 recall events for this product code
- TissueTech, Inc.TerminatedUnknown
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Potential exposure of product to microbial contamination.
Z-0550-2021 · View FDA record ↗ - TissueTech, Inc.TerminatedUnknown
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Potential exposure of product to microbial contamination.
Z-0551-2021 · View FDA record ↗ - TissueTech, Inc.TerminatedUnknown
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Potential exposure of product to microbial contamination.
Z-0552-2021 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code