MalfunctionKDD

CUSTOMEYES KIT CATARACT PACK - SURGERY CENTER

Received Jun 29, 2026 · Event occurred Jun 15, 2026

Report 25650415 · MDR key 25650415

Device

Generic name

Kit, Surgical Instrument, Disposable

Manufacturer

Beaver-visitec International, Inc.

Model number

58001997

Catalog number

58001997

Lot number

6098699

Patient

NA · Unknown

Foreign Body In Patient

Narrative

Description of Event or Problem

FOREIGN OBJECT FOUND WITHIN 4X4 SPONGES, APPEAR TO BE METAL SHAVINGS OR PLASTIC. COULD HAVE ENDED UP IN THE PATIENT'S EYE OR IMPLANT. PREP ALSO WOULD HAVE NOT BEEN STERILE. REMOVED DEFECTIVE PRODUCT AND REDID PREP STAND.