inforMED
MalfunctionMOE

CUSTOM PACK

Received May 18, 2001 · Event occurred Mar 15, 2001

Report 1644019-2001-00016 · MDR key 334144

Device

Generic name

Surgical Pack

Manufacturer

Alcon - Houston

Model number

CUSTOM PAK

Catalog number

CUSTOM PAK

Lot number

190245H

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Skin Discoloration
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

REPORTER NOTED CORNEA PROTECTOR LEFT A CIRCLE ON PT'S EYE WHEN REMOVED. PT'S EYE REQUIRED SCRAPPING OF EPITHELIUM TO REMOVE.

Remedial action

  • Other