Light Adjustable Lens (LAL) 60007-0180Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818806021545), received between Jun 27, 2024 and Apr 21, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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.

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

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ WAS EXPLANTED FROM THE RIGHT EYE AND A NEW LIGHT ADJUSTABLE LENS IMPLANTED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24944987 ↗
• InjuryMar 6, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +18.0D) IN THE LEFT EYE. THE PATIENT COMPLETED 2 LIGHT ADJUSTMENTS ON (B)(6) 2025 BUT DID NOT COMPLETE THE NECESSARY LOCK IN TREATMENTS. ON (B)(6) 2026, THE TREATING PHYSICIAN OBSERVED CENTRAL IOL IRREGULARITIES CONSISTENT WITH PHOTOPOLYMERIZATION. THE LAL+ WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026.

  Patient problems: Visual Impairment

  MAUDE report 24538340 ↗
• InjuryAug 25, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT THE LEADING HAPTIC BECAME DISINSERTED FROM THE OPTIC DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +18.0D). THE LENS WAS LEFT IMPLANTED IN THE EYE DUE TO CONCERNS OF POOR CAPSULAR BAG STABILITY. 11 DAYS LATER, A VITRECTOMY WAS PERFORMED AND THE LAL+ WAS EXPLANTED. A NEW LAL+ WAS IMPLANTED IN THE SULCUS AS A REPLACEMENT VIA THE YAMANE TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891499 ↗
• InjuryMay 21, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +18.0D) COMPLETED TWO LIGHT TREATMENTS AND DID NOT UNDERGO LOCK-IN LIGHT TREATMENTS. APPROXIMATELY 14 MONTHS AFTER IMPLANTATION, THE PATIENT'S LAL+ WAS EXPLANTED DUE TO VISUAL DISTURBANCES ASSOCIATED WITH OBSERVATIONS THAT ARE CONSISTENT WITH ZONE FORMATION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22063334 ↗
• InjuryApr 3, 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), +18.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. A LAL (SN (B)(6), +17.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21763728 ↗
• InjurySep 4, 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, WHILE IMPLANTING THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +18.0D), THE TRAILING HAPTIC DISINSERTED AND NO INTRAOCULAR LENS WAS LEFT IMPLANTED IN THE PATIENT'S EYE THAT DAY. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE ON (B)(6) 2024 IN WHICH AN LAL WAS SUCCESSFULLY IMPLANTED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 08/06/2024.

  Patient problems: Visual Impairment

  MAUDE report 20135675 ↗
• InjuryJun 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), +18.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION AND A NEW LAL+ (SN (B)(6), +19.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024. REFERENCE REPORT #3012712027-2024-00105 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19630669 ↗