PMA

P980040: SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

FDA PMA · Intraocular lens · Johnson & Johnson Surgical Vision, Inc.

Key facts

PMA number P980040
Trade name SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic name Intraocular lens
Applicant Johnson & Johnson Surgical Vision, Inc.
Owner/operator Johnson & Johnson Surgical Vision, Inc.
Product code HQL
Approval date Feb 3, 2000
Docket number 00M=0445
Notice date Feb 16, 2000
Establishment registration 3012236936
FEI number 3012236936

At a glance

  • 100–999 Supplements
  • Jul 23, 2026 Latest supplement decision
  • No Withdrawn
  • Yes Summary of safety and effectiveness on file
  • 1,000+ UDI device identifiers (GUDID)
  • None MAUDE adverse event reports
  • None Recall events

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA approvals

Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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