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Optimum Extra roflufocon D

by Contamac Holdings Limited

Optimum Extra roflufocon D is a Class II device made by Contamac Holdings Limited, cleared under FDA 510(k) K180616 on 25 Apr 2018 (3 earlier submissions) and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 00865576000201), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00865576000201 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180616 Date25 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180616 decided 25 Apr 2018 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00865576000201 listed 22 Jul 2020 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2982-2018 FDA Class III initiated 3 Jul 2018
    • Terminated Z-2981-2018 FDA Class III initiated 3 Jul 2018

    Vials labeled for the prescriptions contained incorrect lenses

Timeline

7 dated events

  1. Cleared FDA 510(k) K033594
  2. Cleared FDA 510(k) K160859
  3. Cleared FDA 510(k) K161100
  4. Cleared FDA 510(k) K180616
  5. Recall initiated FDA recalls Z-2982-2018
  6. Recall initiated FDA recalls Z-2981-2018
  7. Listed FDA GUDID 00865576000201

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optimum Extra
Generic name
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Model / Ref / Catalog
roflufocon D
Primary DI / UDI-DI
00865576000201
510(k) Number
FDA product code
HQD, MUW
GMDN term
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Device class
Class II
Regulation number
886.5916
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid-gas-permeable corrective contact lens, daily-wear

Cleared under the same submission (K033594)

Cleared under the same submission (K160859)

Similar devices

Other devices filed under FDA product code HQD (Lens, Contact (Other Material) - Daily).

Other devices from Contamac Holdings Limited

See all devices from Contamac Holdings Limited →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)