Light Adjustable Lens (LAL) 60007-0250Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818806021675), received between Nov 27, 2024 and Sep 19, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 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), +25.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRED VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23097187 ↗
• InjurySep 17, 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), +25.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRED VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23074612 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DUE TO THE PATIENT MOVING DURING DELIVERY OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +25.0D) . A VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22184928 ↗
• InjuryJun 5, 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), +25.0D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +26.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22154017 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT ON (B)(6) 2024 A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +25.0D) WAS EXPLANTED DUE TO DIPLOPIA AND A NEW LAL (SN (B)(6), +25.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 21930292 ↗
• InjuryFeb 6, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT DURING DELIVERY OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +25.0D), THE TRAILING HAPTIC WAS DISINSERTED FROM THE OPTIC BODY AND THE PATIENT'S ANTERIOR CAPSULE WAS TORN. THE LAL+ WAS REMOVED AND ANOTHER LAL+ (SN: (B)(6), +25.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21323271 ↗
• InjuryNov 27, 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+, SN (B)(6), +25.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR UNCORRECTED DISTANCE VISION, MEASURED AT 20/20-2 VISUAL ACUITY, AND DYSPHOTOPSIA; A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 20792236 ↗