Light Adjustable Lens (LAL) 60007-0090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806021422), received between Nov 26, 2024 and Nov 26, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Optical Decentration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +9.00D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +12.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23658804 ↗
• InjuryJul 22, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +9.0D) WAS EXPLANTED DUE TO LENS DECENTRATION ATTRIBUTED TO POOR CAPSULAR SUPPORT. THE LAL+ WAS EXPLANTED, AND AN ANTERIOR CHAMBER IOL WAS IMPLANTED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22565852 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +9.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCE; A NEW LAL+ (SN (B)(6), +9.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 20780515 ↗