PMA

P930014: ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES

FDA PMA · Intraocular lens · Alcon Laboratories, Inc.

Key facts

PMA number P930014
Trade name ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
Generic name Intraocular lens
Applicant Alcon Laboratories, Inc.
Owner/operator Alcon Laboratories, Inc.
Product code HQL
Approval date Dec 22, 1994
Docket number 96M-0221
Notice date Jul 15, 1996
Establishment registration 1610287
FEI number 1610287

At a glance

  • 100–999 Supplements
  • Jul 8, 2026 Latest supplement decision
  • No Withdrawn
  • No 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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