MAUDE report

MAUDE report 54110: RAY-BAN SUNGLASS

Injury · received Dec 6, 1996 · BAUSCH & LOMB INC.

Key facts

MDR report key 54110
Report number 1643383-1996-00003
Event type Injury
Brand name RAY-BAN SUNGLASS
Model number CATS
Catalog number L1605
Manufacturer BAUSCH & LOMB INC.
Product code HQY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Dec 6, 1996
Report date Dec 5, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 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:

Browse all MAUDE medical device reports