RxSight Light Adjustable Lens (RxLAL) 60005-3170Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00818806020616), received between Oct 21, 2022 and May 22, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Optical Decentration” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Use of Incorrect Control/Treatment Settings

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE RIGHT EYE PRIOR TO ANY LIGHT TREATMENTS DUE TO A REFRACTIVE SURPRISE CAUSED BY AN INCORRECT IOL POWER CALCULATION RESULTING FROM A PREOPERATIVE MEASUREMENT ERROR.

  Patient problems: Blurred Vision

  MAUDE report 25257244 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) WAS IMPLANTED (B)(6) 2026. POSTOPERATIVELY, THE PATIENT COMPLAINED OF VISUAL DISTURBANCES AND DISSATISFACTION WITH VISION PRIOR TO BEGINNING LIGHT TREATMENTS. NO LIGHT TREATMENTS WERE PERFORMED BEFORE THE LAL WAS EXPLANTED ON (B)(6) 2026 DUE TO THE PATIENT'S DISSATISFACTION WITH VISION AND A NEW LAL (+14.0D) WITH A SIGNIFICANT DIOPTER DIFFERENCE WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24794813 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +17.0D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24629769 ↗
• InjuryFeb 11, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) ON (B)(6) 2025. ON POSTOPERATIVE EXAM, ONE OF THE HAPTICS WAS OBSERVED TO BE DISPLACED, AFFECTING THE SHAPE OF THE IRIS AND THE PUPIL. ON (B)(6) 2026, A SECONDARY PROCEDURE WAS PERFORMED TO REPOSITION THE LENS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24317272 ↗
• InjuryAug 18, 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), +17.0D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL (SN (B)(6), +16.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22835661 ↗
• InjuryMay 21, 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), +17.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO DISSATISFACTION WITH VISION.

  Patient problems: Visual Impairment

  MAUDE report 22063420 ↗
• InjuryMay 7, 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), +17.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH DISTANCE VISION AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21980584 ↗
• InjuryOct 16, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) WAS EXPLANTED DUE TO DECENTRATION. A NEW LAL (SN (B)(6), +17.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20466158 ↗
• InjuryMay 17, 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), +17.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO COMPLAINTS OF GLARE AND STARBURSTS. AN INTRAOCULAR LENS (+18.0D) FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT; HOWEVER, THE SITE REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE GLARE AND STARBURSTS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(4) 2024.

  Patient problems: Visual Disturbances

  MAUDE report 19346984 ↗
• InjuryApr 24, 2024Adverse 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) , +17.0D) WAS EXPLANTED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 03/26/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19177175 ↗
• InjuryApr 5, 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) , +17.0D) IN THEIR LEFT EYE WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR INTERMEDIATE VISION. A NEW LAL+ (SN (B)(6) , +16.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/07/2024.

  Patient problems: Blurred Vision

  MAUDE report 19055262 ↗
• InjuryDec 22, 2023Adverse 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)) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION. A LENS OF A DIFFERENT BRAND WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 12/05/2023.

  Patient problems: Visual Impairment

  MAUDE report 18380798 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) WAS EXPLANTED AND ANOTHER LAL WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18022511 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) FROM THE LEFT EYE (OS) WAS EXPLANTED. ANOTHER LAL WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 17909565 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL SN (B)(6)) EXPLANTED FROM HER LEFT EYE (OS) DUE TO BEING DISSATISFIED WITH THE OUTCOME. REFERENCE MDR 3012712027-2023-00064 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Impairment

  MAUDE report 17313198 ↗
• InjuryMar 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(4), +17.0D) WAS EXPLANTED BEFORE ANY LIGHT TREATMENTS DUE TO HAVING A LARGE REFRACTIVE ERROR OF +3.25 -2.25 X042 (MANIFEST REFRACTION). THE EXPLANTED LAL WAS REPLACED WITH ANOTHER LAL WITH A POWER OF +20.5D (SN (B)(4)). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/21/2023.

  Patient problems: Visual Impairment

  MAUDE report 16607689 ↗
• InjuryOct 21, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) HAS BEEN EXPLANTED DUE TO A HYPEROPIC OUTCOME. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15655619 ↗