MalfunctionMSS
RXSIGHT INSERTION DEVICE
Received Apr 17, 2026 · Event occurred Mar 18, 2026
Report 3012712027-2026-00172 · MDR key 24916741
Device
Generic name
Rxsight Insertion Device
Manufacturer
Rxsight, Inc.Model number
63002Catalog number
63002
Lot number
A03-2152
Product problems
- Use of Device Problem
Patient
62 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD FOR THE MANUFACTURING LOT WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. MANUFACTURER REFERENCE #: (B)(4).
Description of Event or Problem
A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED BACKWARDS DURING SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.