Light Adjustable Lens (LAL) 60007-0160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818806021507), received between Jun 18, 2024 and Oct 31, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 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), +16.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES AND BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23438401 ↗
• InjuryJul 25, 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), +16.0D) WAS EXPLANTED FROM THE RIGHT EYE AND REPLACED WITH A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D) DUE TO RESIDUAL REFRACTIVE ERROR AND BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22609570 ↗
• InjuryDec 9, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +16.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO A REFRACTIVE SHIFT FOLLOWING 3 LIGHT ADJUSTMENTS. DURING THE INTRAOCULAR LENS EXCHANGE PROCEDURE, THE SURGEON NOTED THAT THE LENS HAD SHIFTED FORWARD, POSSIBLY DUE TO DAMAGE TO THE HAPTIC OF THE IMPLANTED LAL+.

  Patient problems: Visual Impairment

  MAUDE report 20887289 ↗
• InjuryJun 18, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT DURING PRIMARY CATARACT SURGERY, ON (B)(6) 2024, A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +16.0D) WAS IMPLANTED IN THE PATIENT'S EYE IN ERROR INSTEAD OF THE ORIGINALLY INTENDED LAL+ (+9.0D), RESULTING IN A +6.0D REFRACTIVE SURPRISE POST CATARACT SURGERY. ON (B)(6) 2024, THE LAL+ (SN (B)(6), +16.0D) WAS EXPLANTED AND A NEW LAL+ (+8.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/22/2024.

  Patient problems: Visual Impairment

  MAUDE report 19563155 ↗