RxSight Light Adjustable Lens (RxLAL) 60005-3235Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818806020746), received between May 25, 2022 and Jun 17, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE LEFT EYE PRIOR TO COMPLETING LIGHT TREATMENTS DUE TO PATIENT DISSATISFACTION, BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25536689 ↗
• InjuryJun 11, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT UNDERWENT EXPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL) FROM THE RIGHT EYE PRIOR TO ANY LIGHT TREATMENTS DUE TO A POSTOPERATIVE REFRACTIVE SURPRISE. THIS OUTCOME WAS ATTRIBUTED TO AN ERROR IN PREOPERATIVE AXIAL LENGTH MEASUREMENT. THE EXPLANTED LENS WAS REPLACED WITH A NEW LAL. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25478131 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Visual Impairment

  MAUDE report 25417907 ↗
• InjuryMar 17, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6), +23.5D) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2025. NO LIGHT TREATMENTS WERE PERFORMED BEFORE THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2026 COMPLAINING OF BLURRY VISION. EXAMINATION REVEALED CENTRAL IOL DISTORTION AFTER REPORTED TANNING BED USE. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND A NEW LAL (SN: (B)(6), +24.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24623763 ↗
• InjuryNov 14, 2025Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +23.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. TWO LIGHT TREATMENTS WERE PERFORMED BEFORE THE LAL WAS EXPLANTED AND NEW LAL (SN: (B)(6), +22.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556394 ↗
• InjuryJul 17, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SERIAL NUMBER (B)(6), +23.5D) WAS EXPLANTED DUE TO BLURRY VISION FOLLOWING THE PATIENT'S UNPROTECTED EXPOSURE TO ULTRAVIOLET (UV) LIGHT FROM TANNING BED USE. A REPLACEMENT LAL WAS SUBSEQUENTLY IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 22532856 ↗
• InjuryJul 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), +23.5D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22399747 ↗
• MalfunctionMay 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +23.5D) WAS IMPLANTED BACKWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079818 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RXSIGHT WAS INFORMED OF A REPORT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +23.5D). THE LAL WAS REMOVED FROM THE EYE AND A VITRECTOMY WAS PERFORMED. A NEW LAL WAS IMPLANTED IN THE EYE AND PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 20666898 ↗
• InjuryOct 31, 2023Use of Device Problem; Use of Device Problem

  A USER FACILITY REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +23.5D) WAS EXPLANTED. RXSIGHT'S FIRST AWARENESS OF THE LAL EXPLANTATION EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18040628 ↗
• InjuryOct 19, 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 RIGHT EYE (OD). ANOTHER LAL WAS IMPLANTED AS REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 09/20/2023.

  Patient problems: Visual Impairment

  MAUDE report 17966271 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT DURING THE IMPLANT SURGERY FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +23.5D), A CAPSULAR BAG TEAR OCCURRED. THE SURGEON PLACED THE LAL IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/27/2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 17410606 ↗
• InjuryJan 6, 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)(4), 23.5D) EXPLANTED FROM HIS LEFT EYE (OS) DUE TO THE PATIENT BEING DISSATISFIED WITH HIS VISION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2022. REFER TO MFR REPORT #: 3012712027-2023-00002 FOR INFORMATION ON THE PATIENT'S RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 16118774 ↗
• InjuryJan 6, 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)(4), 23.5D) EXPLANTED FROM HIS RIGHT EYE (OD) DUE TO THE PATIENT BEING DISSATISFIED WITH HIS VISION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2022. REFER TO MFR REPORT #: 3012712027-2023-00003 FOR INFORMATION ON THE PATIENT'S LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 16118765 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(4), 23.5D) WAS EXPLANTED DUE TO IT BEING DELIVERED BACKWARDS INTO THE EYE. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 11/18/2022.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15999693 ↗
• InjuryNov 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) HAS BEEN EXPLANTED PRIOR TO ANY LIGHT TREATMENT DUE TO THE PATIENT HAVING A LARGE REFRACTIVE ERROR OF +3.50 SPHERE. THE EXPLANTED LAL HAD A POWER OF 23.5D. WHILE THE SECOND LAL THAT WAS IMPLANTED HAD A POWER OF 26.0D. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15777450 ↗
• InjuryJun 3, 2022Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS 5/8/2022.

  Patient problems: Visual Impairment

  MAUDE report 14597922 ↗
• InjuryMay 25, 2022Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS 4/27/2022.

  Patient problems: Visual Impairment

  MAUDE report 14501475 ↗