Light Adjustable Lens (LAL) 60007-0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806021385), received between Apr 22, 2025 and Aug 13, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT AN ANTERIOR CAPSULAR BAG TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +5.0D). THE LENS WAS PLACED IN THE CAPSULAR BAG.

  Patient problems: Capsular Bag Tear

  MAUDE report 22795146 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6),+13.0D) WAS EXPLANTED DUE TO BLURRY VISION AFTER THE INCORRECT INTRAOCULAR LENS POWER WAS IMPLANTED. A NEW LAL+ (B)(6), +4.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22342611 ↗
• InjuryApr 22, 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), +5.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR VISION DESPITE ACHIEVING THE INTENDED REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 21884625 ↗