RxSight Light Adjustable Lens (RxLAL) 60005-3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00818806020692), received between Sep 22, 2022 and Jun 10, 2026 — classified as 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Optical Decentration” (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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S INABILITY TO ADJUST TO ANISOMETROPIA. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. THE PATIENT CONTINUED TO STRUGGLE WITH ANISOMETROPIA AFTER THE IOL EXCHANGE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25459438 ↗
• InjuryApr 28, 2026Material Opacification; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL) IN THE RIGHT EYE. DURING THE POSTOPERATIVE PERIOD, THE PATIENT COMPLETED 3 LIGHT ADJUSTMENTS AND DID NOT COMPLETE ANY REQUIRED LOCK-IN TREATMENTS. APPROXIMATELY 30 MONTHS AFTER IMPLANTATION, THE PHYSICIAN NOTED A CENTRAL OPACIFICATION ON THE LAL DURING A SLIT LAMP EXAM THAT IS CONSISTENT WITH PHOTOPOLYMERIZATION, AND THE LAL WAS SUBSEQUENTLY EXPLANTED. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25019344 ↗
• InjuryApr 22, 2026Detachment of Device or Device Component

  A SITE REPORTED TO RXSIGHT THAT THE LIGHT ADJUSTABLE LENS (LAL) WAS NOTED TO BE MISSING THE TRAILING HAPTIC UPON IMPLANTATION AND THE SURGEON DECIDED TO EXPLANT THE LAL. A CAPSULE TEAR OCCURRED DURING EXPLANTATION OF THE LENS. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A NEW LAL WAS IMPLANTED IN THE SULCUS. SUTURES WERE USED TO CLOSE THE INCISION DUE TO THE PATIENT HAVING PRIOR 7-CUT RADIAL KERATOTOMY (RK) SURGERY.

  Patient problems: Capsular Bag Tear

  MAUDE report 24955512 ↗
• InjuryMar 4, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +21.0D) ON (B)(6) 2025, THE TRAILING HAPTIC DISINSERTED. AN ADDITIONAL PROCEDURE WAS PERFORMED ON (B)(6) 2026 TO EXPLANT THE LENS AND IMPLANT A NEW LAL (SN: (B)(6), +21.0D) AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24514279 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D). THE LENS WAS PLACED IN THE SULCUS WITH OPTIC CAPTURE. THE PHYSICIAN ALSO NOTES THAT THE TEMPORAL EDGE OF THE LENS IS CAUSING UVEITIS-GLAUCOMA-HYPHEMA (UGH) SYNDROME.

  Patient problems: Capsular Bag Tear; UGH (Uveitis Glaucoma Hyphema) Syndrome

  MAUDE report 24491856 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D). THE LAL HAPTICS WERE PLACED IN THE SULCUS AND THE OPTIC IN THE CAPSULAR BAG.

  Patient problems: Capsular Bag Tear

  MAUDE report 24379260 ↗
• 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) +21.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378598 ↗
• InjuryFeb 2, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) IN THE RIGHT EYE ON (B)(6) 2023. POST-OPERATIVELY, THE PATIENT COMPLETED 2 LIGHT ADJUSTMENTS AND DID NOT RETURN FOR LOCK-IN TREATMENTS. APPROXIMATELY 26 MONTHS AFTER IMPLANTATION, ON (B)(6) 2025, THE LENS WAS EXPLANTED DUE TO LENS APPEARANCE THAT WAS CONSISTENT WITH POLYMERIZATION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24235291 ↗
• InjuryNov 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), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 23624930 ↗
• InjuryNov 13, 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 A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D). AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23544657 ↗
• InjuryOct 22, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +21.0D) WAS IMPLANTED ON (B)(6) 2023 AND ALL LIGHT TREATMENTS WERE COMPLETED BY ON (B)(6) 2023. DURING A POST-OP EXAM, ON (B)(6) 2025, THE LAL WAS OBSERVED TO BE NASALLY DISPLACED AND THE PATIENT COMPLAINED OF BLURRY NEAR VISION. ON (B)(6) 2025, THE LAL WAS EXPLANTED AND A NEW LAL (SN: (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23357627 ↗
• InjuryAug 27, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) ON (B)(6) 2024. THE PATIENT DID NOT RETURN FOR LIGHT ADJUSTMENTS AND LOCK IN TREATMENTS; THE PATIENT ALSO REPORTED THAT THEY DID NOT WEAR THE UV PROTECTIVE EYEWEAR THEY WERE PROVIDED DURING THE POSTOPERATIVE PERIOD. ON (B)(6) 2025, APPROXIMATELY 10 MONTHS AFTER IMPLANT SURGERY, THE LAL WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE QUALITY OF VISION.

  Patient problems: Blurred Vision

  MAUDE report 22903338 ↗
• InjuryAug 27, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) ON (B)(6) 2025, THE TRAILING HAPTIC DISINSERTED DURING DELIVERY OF THE LAL INTO THE EYE. AN ADDITIONAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE LENS AND IMPLANT A NEW LAL AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22903335 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION. A NEW LAL (SN: (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22795147 ↗
• MalfunctionJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) WAS IMPLANTED BACKWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572533 ↗
• InjuryJul 15, 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), +21.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND BLURRED VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22510462 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULAR BAG WAS PUNCTURED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) FOLLOWING IOL EXCHANGE TO REPLACE A NON-LAL. A VITRECTOMY WAS PERFORMED AND ANOTHER LAL (SN (B)(6), +20.0D) WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22420214 ↗
• InjuryJul 7, 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), +21.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND PATIENT DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22420142 ↗
• InjuryJun 25, 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, (B)(6), +21.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES WHICH BEGAN PRIOR TO LIGHT TREATMENTS. AFTER ATTEMPTING TO REDUCE SYMPTOMS OF HALOS BY REPOSITIONING THE LENS WITH REVERSE OPTIC CAPTURE, A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22330223 ↗
• InjuryMay 28, 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), +21.0D) WAS EXPLANTED PRIOR TO COMPLETION OF LIGHT TREATMENTS DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 22100665 ↗
• InjuryMay 28, 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), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22100664 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED THAT A PATIENT WITH IRREGULAR ASTIGMATISM HAD AN IC-8 IOL EXPLANTED AND REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) ON (B)(6) 2024. AFTER COMPLETING ALL LIGHT TREATMENTS AND MEETING THE PATIENT'S TARGETED REFRACTION, THE PATIENT WAS NOT SATISFIED WITH HER NEAR VISION. ON (B)(6) 2025, THE LAL WAS EXPLANTED AND A MONOFOCAL IOL WAS IMPLANTED AS REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22063333 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 21.0D) ON (B)(6) 2023. ON (B)(6) 2024 AN INTRAOCULAR LENS EXCHANGE WAS ATTEMPTED DUE TO PATIENT DISSATISFACTION WITH NEAR VISION; HOWEVER, THE CAPSULAR BAG WAS STRONGLY ADHERENT TO THE ANTERIOR SURFACE OF THE LAL OPTIC AND THE LENS WAS LEFT IN PLACE. ON (B)(6) 2025 AN ADDITIONAL PROCEDURE WAS PERFORMED TO IMPLANT A SECONDARY REFRACTIVE LENS.

  Patient problems: Blurred Vision

  MAUDE report 22040082 ↗
• InjuryFeb 11, 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), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION. A NEW LAL (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21356901 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WHO WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) IN THE LEFT EYE ON (B)(6) 2022 PRESENTED APPROXIMATELY 21 MONTHS AFTER FINAL LOCK-IN REPORTING DISSATISFACTION WITH NEAR VISION. THE LAL WAS EXPLANTED ON 12/11/2024.

  Patient problems: Visual Impairment

  MAUDE report 21323275 ↗