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Biomedics 55 Asphere Soft Contact Lenses for Extended Wear

by The Cooper Companies

PMA P890023

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P890023↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP890023 Date19 Sep 1989ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0529-2015 FDA Class II initiated 28 Oct 2014

    Portions of the lots may contain units with an incorrect lens axis condition.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Trade Name
H55 Hydrophilic Contact Lens
Generic Name
Lenses, soft contact, extended wear
PMA Number
FDA Product Code
LPM
Device Class
Class III
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Biomedics 55 Asphere soft contact lenses are extended wear hydrophilic lenses made of ocufilcon D material. They are designed for continuous wear and classified as soft contact lenses for extended wear under FDA device classification.

Supplied by The Cooper Companies from Pleasanton, CA, these lenses are authorized under FDA PMA P890023 with product code LPM and regulation number 886.5925. They are reusable

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What material are Biomedics 55 Asphere lenses made of?

    Biomedics 55 Asphere lenses are made of ocufilcon D, a hydrophilic material used in soft contact lenses for extended wear.

  • Are Biomedics 55 Asphere lenses approved for extended wear?

    Yes, Biomedics 55 Asphere lenses are specifically designed and authorized for extended wear, as indicated by their classification as 'Lenses, soft contact, extended wear' in the FDA PMA approval.

  • Who manufactures Biomedics 55 Asphere lenses?

    Biomedics 55 Asphere lenses are manufactured by The Cooper Companies, headquartered in Pleasanton, California.