Skip to content

Kelman Omnifit II Model 2100

by Bausch & Lomb Surgical, Inc.

PMA P850059

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 31 Jul 1986

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP850059 Date31 Jul 1986Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Kelman(Tm) Omnifit II Model 2100
Generic Name
intraocular lens
PMA Number
FDA Product Code
HQL
Device Class
Class III
Regulation
21 CFR Part 886.3600
Advisory Committee
Ophthalmic
FDA Decision
APWD Approval withdrawn