MAUDE report

MAUDE report 65265: PROCLEAR SOFT (HYDROPHILIC) CONTACT LENS

Injury · received Jan 27, 1997 · BIOCOMPATIBLES INC.

Key facts

MDR report key 65265
Report number 1118577-1996-00004
Event type Injury
Brand name PROCLEAR SOFT (HYDROPHILIC) CONTACT LENS
Model number FPS-0001
Manufacturer BIOCOMPATIBLES INC.
Product code LPL
Device class Class II
Date received by FDA Jan 27, 1997
Report date Jan 14, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

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

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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