inforMED
MalfunctionMSS

RXSIGHT INSERTION DEVICE

Received Mar 26, 2026 · Event occurred Feb 23, 2026

Report 3012712027-2026-00133 · MDR key 24702001

Device

Generic name

Rxsight Insertion Device

Manufacturer

Rxsight Inc.

Model number

63001

Catalog number

63001

Product problems

  • Insufficient Device Problem Information

Patient

71 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6),+24.0D) WAS IMPLANTED BACKWARDS DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

Additional Manufacturer Narrative

MANUFACTURER REFERENCE #: (B)(4).