Light Adjustable Lens (LAL) 60007-0140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818806021477), received between Jun 14, 2024 and Jan 21, 2026 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +14.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24138046 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +14.0D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL+ (SN (B)(6), +12.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22522493 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS + (LAL+, (B)(6), +14.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY DISTANCE VISION.

  Patient problems: Blurred Vision

  MAUDE report 20880734 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING PRIMARY CATARACT SURGERY ON (B)(6) 2024, THE EYE'S ANATOMY PROHIBITED PLACEMENT OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +14.0 D) INTO THE CAPSULAR BAG. SULCUS PLACEMENT OF THE LAL+ WAS UNSUCCESSFUL DUE TO A BENT HAPTIC. THE PATIENT WAS DISCHARGED APHAKIC AND RETURNED ON (B)(6) 2024 TO COMPLETE IMPLANTATION WITH AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER.

  Patient problems: Visual Impairment

  MAUDE report 20456668 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE IMPLANTING A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +14.0D) DURING PRIMARY CATARACT SURGERY, DAMAGE TO THE CAPSULAR BAG OCCURRED. A VITRECTOMY WAS PERFORMED AND THE LAL+ WAS IMPLANTED VIA OPTIC CAPTURE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/16/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19538294 ↗