MMCClass II
Dilator, Expansive Iris (accessory)
Ophthalmic · 21 CFR 886.4150
MDR events9All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
9 adverse event reports on file
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12232
- MEDLINEJul 29, 2026MalfunctionMedline Industries, Lp1417592-2026-11493
- MEDLINEJun 22, 2026MalfunctionMedline Industries, Lp1417592-2026-02861
- HUDSON RCIMay 27, 2026MalfunctionMedline Industries, Lp1417592-2026-01799
- MEDLINEMay 17, 2026MalfunctionMedline Industries, Lp1417592-2026-01426
- FITRIGHTMay 11, 2026MalfunctionMedline Industries, Lp1417592-2026-01078
- MEDLINEMar 25, 2026DeathMedline Industries, Lp1417592-2026-00267
- BEEHLERJan 21, 2000InjuryMorice S.a.MW1017979
- TYRRELL IRIS HOOKJul 22, 1993MalfunctionCodman & Shurtleff Inc.8875
Event type breakdown
Malfunction7
Death1
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.