inforMED
MalfunctionMSS

RXSIGHT INSERTION DEVICE

Received Jul 8, 2026 · Event occurred Jun 9, 2026

Report 3012712027-2026-00308 · MDR key 25751691

Device

Generic name

Rxsight Insertion Device

Manufacturer

Rxsight Inc.

Model number

63002

Catalog number

63002

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) FLIPPED TO AN INCORRECT ORIENTATION DURING IMPLANTATION. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

Additional Manufacturer Narrative

MANUFACTURER REFERENCE #: (B)(4).