RxSight Light Adjustable Lens (RxLAL) 60005-3205Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00818806020685), received between Apr 21, 2022 and Sep 18, 2026 — classified as 49 injuries, 1 malfunction.

The most frequently reported specific device problem is “Optical Decentration” (4 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Optical Decentration

  A site reported to RxSight that a patient's Light Adjustable Lens (LAL) was observed to be dislocated during a post-operative exam. An anterior vitrectomy was performed and the LAL was successfully repositioned in the sulcus during a secondary surgery.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50820389 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that during implantation of a Light Adjustable Lens (LAL), a posterior capsule tear occurred during injection of the LAL, and an anterior vitrectomy was performed. The physician subsequently examined the patient and reported that the patient was doing well with no retinal issues on examination.

  Patient problems: Capsular Bag Tear

  MAUDE report 50773358 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens was explanted from the left eye due to a shift in refraction and monocular diplopia after completion of light treatments. A new LAL was implanted as a replacement. No additional information is available.

  Patient problems: Diplopia/Double Vision; Visual Impairment

  MAUDE report 50212626 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED PRIOR TO ANY LIGHT ADJUSTMENTS DUE TO CLOUDY VISION IMMEDIATELY FOLLOWING IMPLANTATION OF THE LAL. A NEW LAL+ WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 25521372 ↗
• InjuryJun 9, 2026Use of Device Problem; Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE RIGHT EYE PRIOR TO ANY LIGHT TREATMENTS DUE TO VISION CHANGES AFTER THE USE OF A TANNING BED WITHOUT RXSIGHT UV PROTECTIVE SPECTACLES. A NEW LAL+ WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25446142 ↗
• InjuryJun 9, 2026Use of Device Problem; Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE LEFT EYE PRIOR TO ANY LIGHT TREATMENTS DUE TO VISION CHANGES AFTER THE USE OF A TANNING BED WITHOUT RXSIGHT UV PROTECTIVE SPECTACLES. A NEW LAL+ WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25446141 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT PRESENTED FOR CATARACT SURGERY WITH A DENSE CATARACT AND A THIN CAPSULAR BAG. FOLLOWING CATARACT REMOVAL, DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS, THE CAPSULAR BAG TORE AS THE LEADING HAPTIC WAS INSERTED. THE LENS WAS SUBSEQUENTLY PLACED IN THE SULCUS. THE PATIENT WAS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 25417908 ↗
• InjuryMay 28, 2026Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE RIGHT EYE AFTER COMPLETION OF LIGHT TREATMENTS DUE TO THE PATIENT'S COMPLAINT OF HAZE AND BLURRED VISION IN BOTH EYES. PRIOR TO EXPLANTING THE LENS, OBJECTIVE MEASUREMENTS OF THE LENS SHOWED INTERNAL ABERRATIONS. POSTOPERATIVELY, THE PATIENT CONTINUED TO COMPLAIN OF HAZY AND BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 25325832 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24879777 ↗
• InjuryApr 3, 2026Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +20.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO THE LENS DISLOCATING DURING PRIMARY CATARACT SURGERY. A NEW LAL (SN (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781628 ↗
• InjuryMar 30, 2026Adverse 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), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES. A NEW LAL+ (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24734673 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DIPLOPIA. THE TREATING PHYSICIAN NOTED A DISTINCT AREA OF CENTRAL SHADOWING ON THE LENS. A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 24571555 ↗
• InjuryFeb 20, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION SECONDARY TO LAL DECENTRATION. A NEW LAL WAS IMPLANTED IN THE SULCUS AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24402997 ↗
• InjuryFeb 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), +20.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378543 ↗
• InjuryFeb 11, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THREE LIGHT TREATMENTS WERE PERFORMED BEFORE THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317198 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +20.5D) WAS IMPLANTED ON (B)(6) 2025. AFTER 2 LIGHT ADJUSTMENTS, THE PATIENT REPORTED VISUAL DISTURBANCES AND BLURRED VISION. ON (B)(6) 2025, THE LAL WAS EXPLANTED DUE TO VISUAL DISTURBANCES, BLURRY VISION AND SUBLUXATION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24087855 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE PATIENT HAD 3 LIGHT TREATMENTS WITH MINIMAL CHANGES IN REFRACTION. ON (B)(6) 2025, A LENS REPOSITIONING PROCEDURE WAS COMPLETED, AND THE LAL WAS FLIPPED INTO THE CORRECT ORIENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961121 ↗
• InjuryDec 22, 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 DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D).

  Patient problems: Capsular Bag Tear

  MAUDE report 23865328 ↗
• InjuryDec 11, 2025Adverse 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 THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS IMPLANTED BACKWARDS. THE SURGEON WAS ABLE TO FLIP THE LAL TO THE CORRECT ORIENTATION. AFTER FLIPPING THE LAL, A CAPSULE TEAR WAS OBSERVED WHEN THE SURGEON NOTED THAT THE LENS WAS TILTING INFERIORLY. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND THE LENS WAS SUCCESSFULLY PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23779727 ↗
• InjuryDec 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), +20.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRED VISION.

  Patient problems: Visual Disturbances

  MAUDE report 23706557 ↗
• MalfunctionSep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6) +20.5D) WAS IMPLANTED IN THE EYE BACKWARDS DURING CATARACT SURGERY. THE LENS WAS FLIPPED TO THE CORRECT ORIENTATION DURING THE SAME SURGERY. A SMALL HEMORRHAGE WAS OBSERVED AFTER FLIPPING THE LENS THAT STOPPED QUICKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034151 ↗
• InjuryJul 9, 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), +20.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION. A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22464299 ↗
• InjuryJun 16, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS IMPLANTED ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT WAS EXPOSED TO UV LIGHT FROM A TANNING BED PRIOR TO STARTING LIGHT TREATMENTS. THE PATIENT REPORTED BLURRY DISTANCE VISION IMMEDIATELY AFTER EXPOSURE AND CONTINUED TO REPORT BLURRY DISTANCE VISION AFTER COMPLETING ONE LIGHT TREATMENT. THE LAL WAS EXPLANTED ON (B)(6) 2025 AND A NEW LAL (SN (B)(6), +25.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22215808 ↗
• InjuryApr 29, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)), THE SURGEON NOTED ONE OF THE HAPTICS HAD DIS-INSERTED LEADING TO POOR IOL CENTRATION. DURING IOL REMOVAL, THE SURGEON ALSO NOTED A POSTERIOR CAPSULAR TEAR AND AN ANTERIOR VITRECTOMY WAS ALSO PERFORMED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT IOL.

  Patient problems: Capsular Bag Tear

  MAUDE report 21929996 ↗
• 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 BILATERALLY IMPLANTED PATIENT HAD ONE OF THEIR LIGHT ADJUSTABLE LENSES (LAL, SN (B)(6), +20.5D) EXPLANTED DUE TO DISSATISFACTION WITH THEIR UNCORRECTED NEAR VISION.

  Patient problems: Blurred Vision

  MAUDE report 21765205 ↗